Explore Studies

NICHD Division/Branch/Center: DER - Pregnancy and Perinatology Branch (PPB)

NICHD Research Networks and Initiatives: Neonatal Research Network

Study Description: This was a multicenter, randomized clinical trial to determine which initial surgical treatment resulted in the lowest rate of death or neurodevelopmental impairment (NDI) in premature infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP). The randomized cohort included 308 infants aged ≤ 8 0/7 weeks of age and ≤ 1,000 g birthweight that were born at centers with the ability to perform both laparotomy and drainage for which a decision was made by the attending pediatric surgeon to perform surgery for suspected NEC or IP. Death or NDI occurred in 69% of infants in the laparotomy group versus 70% with drainage. There was no overall difference in death or NDI rates at 18 to 22 months corrected age between initial laparotomy versus drainage. However, the preoperative diagnosis of NEC or IP modified the impact of initial treatment.

DOI: 10.57982/n04g-am29

Source Repository: DASH

Data Collection Period: 2010-03-08 to 2019-08-22

NICHD Division/Branch/Center: DER - Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)

NICHD Research Networks and Initiatives: Best Pharmaceuticals for Children Act (BPCA)

Study Description: This was a randomized, double-blind, parallel group, dose-ranging, effect-controlled, multicenter study examining the effects of sodium nitroprusside (SNP) in pediatric patients requiring relative induced hypotension during a surgical or medical procedure. The study goals were to define the onset and offset of blood pressure lowering effects of SNP, to construct a dose-response model that defines the relationship between SNP infusion rate and changes in blood pressure in pediatric patients, and to assess the safety of SNP in pediatric patients requiring controlled reduction of blood pressure. Additional goals were to establish the starting and maximum infusion rates for optimum blood pressure control and a safe dosing regimen. A total of 211 participants were enrolled, and 203 included in the intent-to-treat population. Results indicate that a reasonable starting dose for SNP in this group would be 0.3 µg/kg/min. The clinician can then increase infusion rate to achieve the desired reduction in blood pressure.

DOI: 10.57982/xvkr-ca10

Source Repository: DASH

Data Collection Period: 2005-08-03 to 2008-01-10

NICHD Division/Branch/Center: DER - Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)

NICHD Research Networks and Initiatives: Best Pharmaceuticals for Children Act (BPCA)

Study Description: A Phase II, randomized, double-blind, withdrawal to placebo study examining the efficacy, safety, and tolerability of sodium nitroprusside (SNP) in pediatric subjects. Objectives were to determine the persistence of the effect of SNP on blood pressure during stable infusion regimens lasting at least 12 hours and to assess the potential for rebound hypertension during a 30 minute blinded phase following administration of SNP for at least 12 hours when infusion is temporarily discontinued.

DOI: 10.57982/pshr-8e74

Source Repository: DASH

Data Collection Period: 2009-01-15 to 2011-01-15

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Network

Study Description: P1081 was a Phase IV multicenter, randomized, open-label trial comparing the virologic response, safety, and tolerability of raltegravir. The study population included Human Immunodeficiency Virus (HIV)-1 infected pregnant women with a gestational age between 28 and 36 weeks who are antiretroviral (ARV) naïve or have received short-course zidovudine only for prevention of mother-to-child transmission in previous pregnancies, and their infants. The primary objectives were to compare the ability of two triple ARV regimens (one containing efavirenz and the other raltegravir) begun during the third trimester of pregnancy to achieve a viral load of < 200 copies/mL at the time of delivery and compare the safety and tolerability of two triple ARV regimens (one containing efavirenz and the other raltegravir) begun during the third trimester of pregnancy. All women received a randomized regimen from study entry through delivery. The study showed both regimens to be safe and well-tolerated. The rate of suppression at delivery was found to be higher with raltegravir, primarily with those enrolling in the third trimester. Pregnancy outcomes in this study were consistent with previous studies of initiation of other antiretroviral regimens in pregnancy. While the HIV perinatal transmission rate was not significantly different between treatment arms in our study, substantially fewer infants were infected in the raltegravir arm compared to the efavirenz arm. The results of this study support the use of raltegravir in pregnant women who present late for care.

DOI: 10.57982/wz5a-c795

Source Repository: DASH

Data Collection Period: 2013-09-05 to 2018-12-11

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: The primary goal of ATN 084, a pilot study and sub-study of ATN 067, was to explore the feasibility and acceptability of index female recruiters identifying and recruiting their past and present male sexual partners to undergo HIV screening. In addition, the study included female friendship network members of the index recruiters who were enrolled in ATN 067 and were diagnosed with HIV. These young women were asked to recruit their past and present male sex partners to undergo HIV screening. Factors facilitating and hindering HIV screening of the male sexual partners were also examined.

DOI: 10.57982/zqhr-3t26

Source Repository: DASH

Data Collection Period: 2010-08-15 to 2011-07-15

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: A cross-sectional pilot study that enrolled sexually experienced Hispanic/Latina and African American adolescent and young adult women to serve as index recruiters, who in turn recruited members of their female friendship network to undergo HIV screening. Participants were stratified into three groups based on self-reported HIV infection status. The feasibility and acceptability of identifying and recruiting young women who self-disclose their HIV status to serve as index recruiters were examined. Factors facilitating and hindering recruitment of friendship network members to undergo HIV screening, friendship network members undergoing HIV screening, and HIV negative and HIV status unknown index recruiters undergoing HIV screening were also examined.

DOI: 10.57982/3c58-8531

Source Repository: DASH

Data Collection Period: 2009-01-15 to 2010-06-15

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: A randomized, behavioral trial examining whether HIV-infected youth ages 15 to 24 receiving cell phone support with study funded phone plans demonstrated improved ART adherence and viral control during the 24 week intervention and 24 week post-intervention periods, compared to controls. Participants were randomized to either the intervention or control group. Intervention group participants received Monday through Friday cell phone support from an Adherence Facilitator, including reminders, assessment of barriers to adherence, problem solving and referrals to services. Control group participants completed all on-study evaluations, except intervention exit interviews.

DOI: 10.57982/8t1q-jn35

Source Repository: DASH

Data Collection Period: 2009-10-15 to 2011-11-11

NICHD Division/Branch/Center: N/A

NICHD Research Networks and Initiatives: Prenatal Alcohol and SIDS and Stillbirth (PASS) Network

Study Description: The Safe Passage Study was a large, prospective, multidisciplinary study designed to (1) investigate the association between prenatal alcohol exposure, sudden infant death syndrome (SIDS), and stillbirth, and (2) determine the biological basis of the spectrum of phenotypic outcomes from exposure, as modified by environmental and genetic factors that increase the risk of stillbirth, SIDS, and in surviving children, fetal alcohol spectrum disorders. The study enrolled pregnant people from the Northern Plains, US, and Cape Town, South Africa, areas known to be of high risk for maternal drinking during pregnancy. Research visits occurred during prenatal, delivery/newborn, and postnatal periods through 1 year post-delivery. The Safe Passage Study was the first multi-site study of SIDS and stillbirth to integrate prospectively collected exposure information with multidisciplinary biological information in the same maternal and fetal/infant dyad using a common protocol. Essential components of the study design and its success were close ties to the community and rigorous systems and processes to ensure compliance with the study protocol and procedures.

DOI: 10.57982/sv8c-4y07

Source Repository: DASH

Data Collection Period: 2007-08-01 to 2016-01-01

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: NICHD International Site Development Initiative (NISDI)

Study Description: Describes the demographic, clinical, immunologic, and virologic characteristics of HIV-exposed uninfected infants and HIV-infected infants, children, and adolescents at clinical sites in Latin America. Biospecimens are available for request through DASH. Please navigate to Explore Biospecimens at the top of this page.

DOI: 10.57982/cs3w-p703

Source Repository: DASH

Data Collection Period: 2002-07-15 to 2011-11-30

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: NICHD International Site Development Initiative (NISDI)

Study Description: Describes the characteristics of HIV-infected pregnant women and their HIV-exposed, uninfected children at clinical sites in Latin America, including the utilization of interventions related to decreasing the risk of mother-to-child transmission. Biospecimens are available for request through DASH. Please navigate to Explore Biospecimens at the top of this page.

DOI: 10.57982/jg5w-6h69

Source Repository: DASH

Data Collection Period: 2008-07-15 to 2011-07-15

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: NICHD International Site Development Initiative (NISDI)

Study Description: Describes the characteristics of HIV-infected pregnant women and their HIV-exposed infants at participating clinical sites in Latin America and the Caribbean, including the utilization of interventions related to decreasing the risk of mother-to-child transmission. Biospecimens are available for request through DASH. Please navigate to Explore Biospecimens at the top of this page.

DOI: 10.57982/r7my-4b90

Source Repository: DASH

Data Collection Period: 2002-09-15 to 2011-11-30

NICHD Division/Branch/Center: DER - Fertility and Infertility Branch (FIB)

NICHD Research Networks and Initiatives: Reproductive Medicine Network (RMN)

Study Description: This was a multi-center, prospective, double-blind clinical trial of physiologic (5%) oxygen tension in culture media vs. standard of care, atmospheric (SOC, 20%) oxygen tension with 840 eligible couples recruited to participate. The randomization scheme was coordinated through the central data coordinating center, and the randomization was stratified by age group of the woman (18-34, 35-37, 38-39, and 40-42) and each participating site. Couples were randomized to either have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere or in the currently widely used atmospheric (20%) oxygen atmosphere.

DOI: 10.57982/6enr-8046

Source Repository: DASH

Data Collection Period: 2010-03-15 to 2014-02-03

NICHD Division/Branch/Center: DER - Pregnancy and Perinatology Branch (PPB)

NICHD Research Networks and Initiatives: Neonatal Research Network

Study Description: This study tested whether Neonatal Intensive Care Unit (NICU) teams trained in benchmarking - comparing care practices between different NICUs to see which practices prevent bronchopulmonary dysplasia (BPD) - and quality improvement would change practices and improve rates of survival without BPD in inborn neonates with birth weights of <1250 grams. Benchmarking is a method involving detailed comparisons of processes between similar organizations. For this study, three NRN centers with the lowest rates of BPD were identified as Benchmark centers. During a 6-month pre-intervention period, details of care practices and management style at these centers were carefully assessed. Based on practices at these Benchmarking sites, a quality improvement program was developed. A total of 14 other NRN sites were randomized to either implement the benchmarking intervention (intervention sites) or continue with their usual care practices (control sites). After the 1-year intervention period, changes in the rate of survival without BPD at 36 weeks corrected age were compared between the intervention and control sites. Intervention centers implemented potentially better practices successfully; changes included reduced oxygen saturation targets and reduced exposure to mechanical ventilation. Lower oxygen saturation targets reduced oxygen levels in the first week of life. Despite these changes, rates of survival free of BPD were all similar between intervention and control groups and remained significantly less than the rate achieved in the best-performing centers (73.3%).

DOI: 10.57982/g27w-aq15

Source Repository: DASH

Data Collection Period: 2000-10-01 to 2005-04-21

NICHD Division/Branch/Center: DER - Pregnancy and Perinatology Branch (PPB)

NICHD Research Networks and Initiatives: Neonatal Research Network

Study Description: The Hydrocortisone and Extubation study tested the safety and efficacy of a 10-day course of hydrocortisone for infants who were less than 30 weeks estimated gestational age and who were intubated at 14-28 days of life. Infants were randomized to receive hydrocortisone or placebo. The study determined that hydrocortisone treatment starting on postnatal day 14 to 28 did not result in substantially higher survival without moderate or severe bronchopulmonary dysplasia than placebo. Survival without moderate or severe neurodevelopmental impairment did not differ substantially between the two groups.

Source Repository: DASH

Data Collection Period: 2011-08-11 to 2020-09-21

NICHD Division/Branch/Center: DER - Pregnancy and Perinatology Branch (PPB)

NICHD Research Networks and Initiatives: Maternal-Fetal Medicine Units (MFMU) Network

Study Description: The primary objective of the Progesterone randomized trial was to determine whether 17 alpha-hydroxyprogesterone caproate (17P) reduced the risk of preterm birth in people who had a previous early spontaneous preterm birth. Participants were enrolled at 16 to 20 weeks of gestation and randomly assigned in a 2:1 ratio to receive either weekly injections of 250 mg of 17P or weekly injections of a placebo. Treatment with 17P significantly reduced the risk of delivery at less than 37 weeks of gestation. Infants of people treated with 17P had lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen. A follow-up study of the children from the trial was conducted to determine whether there were differences in achievement of developmental milestones between treatment groups. No significant differences were seen in health status or physical examination. Scores for Preschool Activities Inventory were within the normal range and similar between groups.

DOI: 10.57982/n6rh-je89

Source Repository: DASH

Data Collection Period: 1999-09-15 to 2005-11-15

NICHD Division/Branch/Center: DER - Gynecologic Health and Disease Branch (GHDB)

NICHD Research Networks and Initiatives: Pelvic Floor Disorders Network (PFDN)

Study Description: This study will determine which, if any, clinical tests are useful for predicting post-operative urinary incontinence. The study will also determine if a Burch urethropexy should be performed routinely or selectively at the time of sacrocolpopexy in continent women.

DOI: 10.57982/g7qt-4q40

Source Repository: DASH

Data Collection Period: 2002-04-15 to 2007-04-15

NICHD Division/Branch/Center: DER - Pregnancy and Perinatology Branch (PPB)

NICHD Research Networks and Initiatives: Maternal-Fetal Medicine Units (MFMU) Network

Study Description: This study was a randomized trial of 6106 pregnant participants randomized at 38 weeks gestation to either elective induction of labor at 39 weeks gestation or expectant management. The primary research question was does elective induction of labor in nulliparous women at 39 weeks improve perinatal outcome compared with expectant management? Women in the induction group were assigned to undergo induction of labor at 39 weeks 0 days to 39 weeks 4 days. Women in the expectant management group were asked to forego elective delivery before 40 weeks 5 days and to have delivery initiated no later than 42 weeks 2 days. The primary outcome was a composite of perinatal death or severe neonatal complications. There was not a statistically significant difference in the frequency of the primary outcome between groups. There was a significantly lower frequency of cesarean delivery, the principal secondary outcome, in the induction group than in the expectant management group.

DOI: 10.57982/yxf2-1243

Source Repository: DASH

Data Collection Period: 2014-03-15 to 2017-10-15

NICHD Division/Branch/Center: DER - Pregnancy and Perinatology Branch (PPB)

NICHD Research Networks and Initiatives: Maternal-Fetal Medicine Units (MFMU) Network

Study Description: This study is a randomized placebo-control trial to test the hypothesis that among patients with at least one prior spontaneous preterm delivery, receiving weekly 17-hydroxyprogesterone caproate with the addition of an omega-3 supplement would further reduce the rate of recurrent preterm birth. Patients were assigned to either a daily 1200mg omega-3 supplement or matching placebo from 16–22 through 36 weeks of gestation. All participants received 250mg weekly intramuscular 17-hydroxyprogesterone caproate. A total of 434 patients were randomly assigned to the omega-3 supplement arm and 418 patients to the placebo arm. Daily supplementation with 1,200 mg of EPA and 800 mg of DHA did not reduce the rate of repeat preterm birth before 37 weeks, before 35 weeks, or before 32 weeks among high-risk patients receiving 17-hydroxyprogesterone caproate.

DOI: 10.57982/vn81-6740

Source Repository: DASH

Data Collection Period: 2005-01-15 to 2007-03-15

NICHD Division/Branch/Center: DER - Pregnancy and Perinatology Branch (PPB)

NICHD Research Networks and Initiatives: Maternal-Fetal Medicine Units (MFMU) Network

Study Description: The purpose of this study was to determine whether levothyroxine treatment of women who are identified as having subclinical hypothyroidism or hypothyroxinemia during pregnancy improves cognitive function in their children. Women with a singleton pregnancy before 20 weeks’ gestation were screened for subclinical hypothyroidism, defined as a thyrotropin level of 4.0 mU/L or more and normal free T4 (0.86-1.9 ng/dL), and for hypothyroxinemia, defined by normal thyrotropin level (0.08–3.99 mU/L) but low free T4 (<0.86dL). In separate trials for the two conditions, women were randomly assigned to levothyroxine or placebo. Thyroid function was assessed monthly and levothyroxine dose adjusted to attain a normal thyrotropin or free T4, respectively, with sham adjustments for placebo. Children underwent annual developmental and behavioral testing for five years. The primary outcome was death or IQ score at age 5 (3 if the 5-year examination was missing).

DOI: 10.57982/ccfh-ns90

Source Repository: DASH

Data Collection Period: 2006-10-15 to 2015-10-15

NICHD Division/Branch/Center: DER - Gynecologic Health and Disease Branch (GHDB)

NICHD Research Networks and Initiatives: Pelvic Floor Disorders Network (PFDN)

Study Description: The primary purpose of this randomized clinical trial was to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS). Postmenopausal women requesting surgery for symptomatic uterovaginal prolapse were randomized to receive one of the procedures and were then followed at 6-month intervals for 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. The study found that sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy after 5 years of follow-up.

DOI: 10.57982/t27x-9e36

Source Repository: DASH

Data Collection Period: 2013-04-03 to 2020-03-27

NICHD Division/Branch/Center: DER - Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)

NICHD Research Networks and Initiatives: Best Pharmaceuticals for Children Act (BPCA)

Study Description: The second of two multiphase, multicenter trials that comprehensively examined lithium in the treatment of pediatric patients with bipolar I disorder. In the first phase, the Efficacy Phase, participants were randomized to either lithium or placebo for 8 weeks to determine efficacy. Eligible participants then continued in the Long-Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment. Subsequently, participants meeting response criteria during the Long-Term Effectiveness Phase were eligible to continue in the Discontinuation Phase, when they were randomized to either placebo or lithium treatment for up to 28 weeks. Finally, those participants who experienced a mood relapse during the Discontinuation Phase were enrolled in an Open Label Restabilization Phase and treated with lithium for up to 8 weeks.

DOI: 10.57982/4x6x-sd62

Source Repository: DASH

Data Collection Period: 2010-05-04 to 2013-03-19

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: Suboptimal response to hepatitis B vaccination in HIV-positive adults and children has been well documented in the literature. This Phase 4 trial compared the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age. The three vaccination schemas were the standard adult dosing of hepatitis B virus (HBV)-only vaccine (Engerix 20mcg), the increased adult dosing of HBV-only vaccine (Engerix 40 mcg), and the standard adult dosing of combined HBV/hepatitis A virus vaccine (Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg), all at Entry, Week 4, and Week 24. Primary sero-reponses were evaluated at Week 28, and primary non-responders (antibody response of < 10 IU/ml) were provided with a booster vaccine using the increased-dose Engerix-B vaccine at Week 48.

DOI: 10.57982/04gk-kd23

Source Repository: DASH

Data Collection Period: 2004-06-15 to 2009-05-15

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: This study developed a culturally appropriate secondary prevention intervention for young HIV+ women through focus groups. Focus groups were digitally recorded and transcribed. Focus groups informed the development of the intervention's framework and content areas. The intervention aimed to reduce the risk of young women infected with HIV transmitting the virus to their sexual partners, and to prevent young women infected with HIV from re-infection with a new viral strain or co-infection with another sexually transmitted disease.

DOI: 10.57982/v659-y740

Source Repository: DASH

Data Collection Period: 2009-03-15 to 2009-04-15

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: An exploratory mixed-methods study comparing a behavioral HIV-prevention intervention (Many Men, Many Voices or 3MV) alone to 3MV combined with a biomedical intervention (Pre-exposure Prophylaxis or PrEP). After completing the 3MV intervention, participants were randomly assigned to one of three study arms: 1) daily PrEP with emtricitabine and tenofovir (FTC/TDF); 2) placebo pill control; or 3) “no pill” control. Behavioral and biomedical data were collected at baseline and every 4 weeks for 24 weeks. Qualitative interviews with a subset of participants were completed at the end of the study to explore the feasibility and acceptability of the trial. Eligible youth who declined to participate were asked to complete a brief opinion survey about PrEP. In addition, a focus group was conducted with young men ages 16-17 years who have sex with men and who met all eligibility requirements except for age to discuss issues of feasibility and acceptability should they be eligible to enroll in a future similar trial.

DOI: 10.57982/65h7-1e78

Source Repository: DASH

Data Collection Period: 2009-12-15 to 2011-09-15

NICHD Division/Branch/Center: DER - Pediatric Trauma and Critical Illness Branch (PTCIB)

NICHD Research Networks and Initiatives: Collaborative Pediatric Critical Care Research Network (CPCCRN)

Study Description: This study examined the relationship between clinical and biological markers with mortality, long-term outcomes, and new morbidities among survivors of acute respiratory distress syndrome (ARDS). This prospective longitudinal observational cohort study attempted to characterize prognostic and predictive biomarkers and provide a link between these biomarkers and the development of clinically relevant clinical outcomes. The molecular phenotypes defined and knowledge acquired is intended to lead to development of precision medicine strategies targeting therapeutic agents to patients with specific molecular phenotypes or biomarker patterns. The study found that children with ARDS are at risk for worsening health-related quality of life and functional status, which can persist up to nine months after their illness.

DOI: 10.57982/b1cw-4y52

Source Repository: DASH

Data Collection Period: 2019-03-22 to 2020-11-30

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: This project tested an adaptive adherence intervention to improve self-management and achieve/maintain viral load suppression while understanding the context for wide-scale implementation in an effectiveness-implementation Type 1 Hybrid trial. Primary aims: 1) Compare cell phone support (CPS) vs. text messaging (SMS) for youth living with HIV (YLH) not virally suppressed; 2) Understand the benefits of incentives for non-responders (NRsp), identify how to taper interventions for responders (Rsp), and describe potential moderators of treatment effect; 3) Study barriers and facilitators to wide-spread implementation and cost-effectiveness of treatment sequences. We hypothesized that youth randomized to CPS will have significantly greater viral load suppression (primary outcome) and self-reported medication adherence (secondary outcome) than those in the SMS group.

DOI: 10.57982/g613-zq04

Source Repository: DASH

Data Collection Period: 2018-07-10 to 2021-12-28

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Pediatric HIV/AIDS Cohort Study (PHACS)

Study Description: This study investigated the long-term outcomes of perinatal HIV (PHIV) and its treatment on young adults with perinatally acquired HIV (YAPHIV). The primary objectives were to: 1) identify infectious and non-infectious complications of HIV disease and toxicities resulting from long-term ART; 2) define the impact of HIV infection and ART on the long-term clinical outcomes in YAPHIV; and 3) define the impact of perinatal HIV infection, its concomitant risk factors, and ART on long-term mental and behavioral health outcomes. Data collection included clinical assessments, online surveys, interviews, specimen collection, and medical chart abstraction, designed to achieve the primary objectives, as well as the domain specific study aims. Results can be used to help design intervention strategies to improve the quality of life of young adults with perinatal HIV.

DOI: 10.57982/06c6-2p87

Source Repository: DASH

Data Collection Period: 2017-09-14 to 2025-03-31

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Pediatric HIV/AIDS Cohort Study (PHACS)

Study Description: This study investigated the long-term outcomes of perinatal HIV (PHIV) and its treatment on young adults with perinatally acquired HIV (YAPHIV). Young adults living with perinatal HIV exposure without perinatally acquired HIV (YAPHEU) were also enrolled. The primary objectives were to: 1) identify infectious and non-infectious complications of HIV disease and toxicities resulting from long-term ART; 2) define the impact of HIV infection and ART on the long-term clinical outcomes in YAPHIV; and 3) define the impact of perinatal HIV infection, its concomitant risk factors, and ART on long-term neurocognitive and behavioral health outcomes. Data collection included clinical assessments, online surveys, interviews, laboratory testing, specimen collection, and medical chart abstraction, designed to achieve the primary objectives and domain specific study aims. Results can be used to help design intervention strategies to improve the quality of life of young adults with perinatal HIV.

DOI: 10.57982/sec9-ja47

Source Repository: DASH

Data Collection Period: 2014-05-12 to 2025-03-31

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Pediatric HIV/AIDS Cohort Study (PHACS)

Study Description: The PHACS AMP study is designed to define the impact of HIV infection and antiretroviral therapy on pre-adolescents and adolescents with perinatal HIV infection. Domains investigated include growth and sexual maturation; metabolic risk factors for cardiovascular disease; cardiac function; bone health; neurologic, neurodevelopment, language, hearing, and behavioral function; and adolescent gynecology and HPV infection. Biospecimens are available.

DOI: 10.57982/y9rz-pg50

Source Repository: DASH

Data Collection Period: 2007-03-26 to 2020-06-10

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: A Phase II, one-arm, pre-/post-test experimental design evaluating the feasibility, acceptability, and preliminary effectiveness of a small-group, peer-network behavioral intervention among adolescent males and females and their friendship networks. Index friends recruited members of their social network to comprise small cohorts of 8 to 16 adolescents who received the group intervention at the same time. The intervention was delivered in six small-group sessions conducted over a three week (two sessions per week) or six week (one session per week) period. The intervention focused on reducing risky sexual behavior, such as the concurrent use of alcohol and marijuana during sex, and increasing condom use.

DOI: 10.57982/m5bs-xz03

Source Repository: DASH

Data Collection Period: 2005-02-15 to 2006-03-15

NICHD Division/Branch/Center: DER - Pregnancy and Perinatology Branch (PPB)

NICHD Research Networks and Initiatives: Neonatal Research Network

Study Description: Despite prevalence of infants exposed to opioids prenatally and who develop NOWS, little evidence exists on the best approaches to identify, monitor, and treat these infants. As a result, there is considerable practice variation across and even within centers. This study systematically collected existing patient-level data, using retrospective chart review, to determine current practices in the care of infants with NOWS at sites associated with ISPCTN and NRN. Data was abstracted from the infants’ records as well as the mothers’ records when her records were available at the site. As a result of the analysis, we have a better understanding of the current practices, and practice variation that exists between these sites. These findings determined the priorities for, and informed the design of, two new clinical trials to improve the care and outcomes for infants with NOWS.

DOI: 10.57982/ye7z-n835

Source Repository: DASH

NICHD Division/Branch/Center: DER - Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)

NICHD Research Networks and Initiatives: Best Pharmaceuticals for Children Act (BPCA)

Study Description: Aim: NICHD-2012-AMP01 study was designed to characterize the pharmacokinetics (PK) and safety of ampicillin administered to infants per standard of care to address gap in pediatric labeling. Methods: The PK analysis include ampicillin data from NICHD-2011-POP01 study. The safety analysis includes ampicillin data from 1) NICHD-2011-POP01 study 2) Pediatric Pharmacology Research Unit (PPRU) study and 3) Pediatrix Medical Group Database. Results: No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to Ampicillin were reported. From the Pediatrix database Adverse events during ampicillin exposure were uncommon. Shorter dosing intervals were associated with more frequent hematologic AEs for infants of all age groups.

DOI: 10.57982/84p7-c722

Source Repository: DASH

Data Collection Period: 2006-01-01 to 2010-11-01

NICHD Division/Branch/Center: DER - Pregnancy and Perinatology Branch (PPB)

NICHD Research Networks and Initiatives: Maternal-Fetal Medicine Units (MFMU) Network

Study Description: This study, also known as the Cesarean Registry, was a prospective four-year observational study of all women with a singleton gestation and a prior cesarean delivery at 19 academic medical centers. Maternal and perinatal outcomes were compared between women who underwent a trial of labor and women who had an elective repeated cesarean delivery without labor. The primary objective was to determine the efficacy and safety of trial of labor in this population. The primary analysis concluded that a trial of labor by women with a history of cesarean delivery is associated with an increased risk of adverse perinatal outcomes and a higher rate of maternal adverse events, as compared with elective repeated cesarean delivery. The magnitude of these risks is small; however, this information is important for women and health care providers who are making choices about the type of delivery. The data released in DASH contains 70,411 women and 73,257 infants. Eight centers participated throughout the four years while eleven participated for two years. Demographic data, details of the obstetrical history, and information about intrapartum and postpartum events were recorded. Neonatal data were collected up to 120 days after delivery or at the time of hospital discharge, including the clinical course for infants admitted to the NICU. Separate data-collection forms were completed for maternal or infant complications.

DOI: 10.57982/10vw-w449

Source Repository: DASH

Data Collection Period: 1999-01-01 to 2003-05-02

NICHD Division/Branch/Center: DER - Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)

NICHD Research Networks and Initiatives: Best Pharmaceuticals for Children Act (BPCA)

Study Description: An open label study to describe the safety and pharmacokinetics of intravenous acyclovir in premature infants with suspected systemic herpes simplex virus (HSV) infection. Dosing group assignments were based on gestational age (GA) and postnatal age (PNA). Protocol version 1.0 (n=13) included four groups, with GA 23-42 weeks and PNA up to 60 days; version 2.0 (n=19) included three groups, with GA 23-34 weeks and PNA <45 days. Acyclovir was administered every 8-12 hours for up to 3 days and was well tolerated. This study was conducted by the Pediatric Trials Network under the Best Pharmaceuticals for Children Act Program. Biospecimens were collected but are not currently available.

DOI: 10.57982/ce5c-dk43

Source Repository: DASH

Data Collection Period: 2011-09-19 to 2012-06-04

NICHD Division/Branch/Center: DER - Pregnancy and Perinatology Branch (PPB)

NICHD Research Networks and Initiatives: Global Network for Women's and Children's Health Research

Study Description: ACT, funded by the NICHD, studied the feasibility, effectiveness and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids (ACS) at all levels of health care in low- and middle-income countries. Investigators conducted a two-arm parallel cluster randomized trial of women enrolled in the Global Network Maternal Newborn Health Registry. Intervention clusters received health-provider training, posters, pregnancy disc, and uterine height tape to facilitate identification of women at risk of preterm birth, and ACS kits. All health providers in intervention clusters were trained to identify women presenting before 36 weeks’ gestation with signs of labor, PPROM, pre-eclampsia/eclampsia, or obstetric hemorrhage as at high risk of preterm birth and potential candidates for ACS. The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birth weight (a proxy for preterm birth).

DOI: 10.57982/f171-tz28

Source Repository: DASH

Data Collection Period: 2011-10-01 to 2014-03-31

NICHD Division/Branch/Center: DER - Pregnancy and Perinatology Branch (PPB)

NICHD Research Networks and Initiatives: Maternal-Fetal Medicine Units (MFMU) Network

Study Description: The Antenatal Late Preterm Steroids Trial (ALPS) was a randomized, multicenter, double-blind trial to determine whether antenatal corticosteroids given to women at high risk for late preterm birth (34 weeks to 36 weeks) reduces stillbirth or the need for neonatal respiratory support of preterm birth or neonatal death in the first 72 hours. Women with a singleton pregnancy at 34-36 weeks who were at high risk for preterm delivery were randomized to 2 injections of betamethasone or matching placebo 24 hours apart. There were 2831 women randomized; 4 were lost to follow-up. The primary outcome occurred in 165 infants (11.6%) in the betamethasone group and 202 (14.4%) in the placebo group (RR 0.80; 95% CI, 0.66-0.97; p=0.02). Severe respiratory complications, transient tachypnea of the newborn, surfactant use, and bronchopulmonary dysplasia also occurred significantly less frequently in the betamethasone group. Neonatal hypoglycemia was more common in the betamethasone group (p<0.001).

DOI: 10.57982/e8bm-m516

Source Repository: DASH

Data Collection Period: 2010-10-19 to 2015-11-13

NICHD Division/Branch/Center: DER - Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)

NICHD Research Networks and Initiatives: Best Pharmaceuticals for Children Act (BPCA)

Study Description: NICHD-2013-ABS01 was a prospective, open-label, partially randomized, multicenter trial. The primary objective of this study was to evaluate the safety of drug regimens consisting of ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, and gentamycin in assigned or standard of care groups of infants with complicated intra-abdominal infections. Secondary objectives included evaluations of efficacy and population pharmacokinetics (PK). Results demonstrate that metronidazole therapy at the protocol-specified doses was safe for premature infants with complicated intra-abdominal infections (Group 1) and late preterm/term infants (Group 4). Therapeutic success was achieved in 81% and 96% of participants in Groups 1 and 4, respectively. Only one AE in each group was attributable to study drug. None of the outcomes of special interest were attributable to metronidazole. Collected PK data validated the protocol-specified dosing regimen.

Source Repository: DASH

Data Collection Period: 2014-05-16 to 2017-03-21

NICHD Division/Branch/Center: DER - Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)

NICHD Research Networks and Initiatives: Best Pharmaceuticals for Children Act (BPCA)

Study Description: NICHD-2013-ABS01 was a prospective, open-label, partially randomized, multicenter trial. The primary objective of this study was to evaluate the safety of drug regimens consisting of ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, and gentamycin in assigned or standard of care groups of infants with complicated intra-abdominal infections. Secondary objectives included evaluations of efficacy and population pharmacokinetics (PK). Results demonstrate that clindamycin therapy at the protocol-specified doses was safe for premature infants with complicated intra-abdominal infections. Only one adverse event was attributed to the study drug, and mortality within 30 days post-treatment was 7% in the cohort receiving the ampicillin, gentamycin, and clindamycin drug regimen (Group 2). None of the outcomes of special interest were attributable to clindamycin. Therapeutic success was achieved in 87% of participants. Collected PK data validated the protocol-specified dosing regimen.

DOI: 10.57982/m14h-jc69

Source Repository: DASH

Data Collection Period: 2014-05-16 to 2017-03-21

NICHD Division/Branch/Center: DER - Pregnancy and Perinatology Branch (PPB)

NICHD Research Networks and Initiatives: Maternal-Fetal Medicine Units (MFMU) Network

Study Description: The Assessment of Perinatal EXcellence (APEX) study is an observational study designed to assist in the development of quality measures for intrapartum care. The specific aim was to assess whether and to what extent hospital differences in the frequency of adverse obstetric outcomes are related to patient and hospital characteristics and to types of care provided. Data were collected on eligible patients if they delivered during the 24-hour period of selected days during a 3-year period. Days were chosen via computer-generated random selection and stratified by weekdays, weekends, and holidays. On selected days, the labor and delivery logbook at each center was screened to identify eligible women. The medical records of all eligible women and their newborns were abstracted by trained research personnel at the hospital and entered into a web-based data entry system. Maternal data were collected until discharge and neonatal data were collected until discharge or 120 days of age, whichever came first.

Source Repository: DASH

Data Collection Period: 2008-03-15 to 2011-02-15

NICHD Division/Branch/Center: DER - Pregnancy and Perinatology Branch (PPB)

NICHD Research Networks and Initiatives: Global Network for Women's and Children's Health Research

Study Description: The purpose of this study was to learn whether a daily 81 mg dose of aspirin given to Nulliparas, beginning between 6-13 weeks of pregnancy, and continuing until 36 weeks of pregnancy, can reduce the risk of preterm birth. Nulliparous women appeared to be an ideal population since they will not undergo special interventions in an attempt to avoid preterm birth and are high risk pregnancies. The study design was a randomized, placebo-controlled, double-blinded multicenter clinical trial to assess the efficacy of Low Dose Aspirin (LDA) in the reduction of preterm birth. Women were randomized equally to receive either daily LDA (81 mg) or a placebo beginning between 6 0/7 weeks and 13 6/7 weeks Gestational Age (GA) and continued until 36 0/7 weeks GA or delivery. The primary outcome of this study was preterm birth, which will be defined as delivery at or after 20 0/7 weeks and prior to 37 0/7 weeks determined by comparing actual delivery date to the projected Estimated Due Date (EDD).

DOI: 10.57982/aeve-8753

Source Repository: DASH

Data Collection Period: 2016-03-23 to 2019-04-11

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: A mixed-methods study to characterize the HIV prevention and care continua among Transgender and Other Gender Minority Youth (TGMY) ages 16-24. Quantitative surveys and qualitative interviews were conducted with TGMY in care and TGMY not in care. In addition, qualitative interviews were conducted with health care and social service providers who work with TGMY. This study assessed transgender youth experiences with accessing services along the HIV prevention and care continua, including barriers and facilitators to service engagement.

DOI: 10.57982/wqnc-6t37

Source Repository: DASH

Data Collection Period: 2015-07-15 to 2016-01-15

NICHD Division/Branch/Center: DER - Pediatric Trauma and Critical Illness Branch (PTCIB)

NICHD Research Networks and Initiatives: Collaborative Pediatric Critical Care Research Network (CPCCRN)

Study Description: Injury prevention and treatment advances have led to substantial declines in mortality in children. Although pediatric trauma mortality has declined, mortality remains the most common outcome measure for assessing quality and comparing treatments. It is critical to have generalizable approaches for measuring short- and long-term outcomes that can be used for assessing children with a wide range of injuries in diverse clinical settings, beyond mortality. The rationale for this proposed research was to determine if establishing the utility and feasibility of brief instruments that measure the relevant outcome of functional status at the time of hospital discharge would facilitate the evaluation and comparison of the care of children with a diverse range of injuries in a range of settings. Overall, this study aimed to develop and improve current metrics for evaluating quality within and between healthcare systems. The TOUCH study found most injured children and adolescents returned to baseline functional status by hospital discharge. These findings suggested that functional status assessments can be limited to cohorts of injured children and adolescents at the highest risk for impairment.

DOI: 10.57982/86ag-y926

Source Repository: DASH

Data Collection Period: 2018-03-02 to 2020-08-30

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: A sub-study of ATN 071 ("Neurocognitive Assessment in Youth Initiating HAART"), ATN 101 was an exploratory assessment comparing the results of a comprehensive neurocognitive evaluation carried out through ATN 071 to biomarkers within the plasma that correlate with immune activation, inflammation, and microbial translocation among study participants. Neurocognitive evaluations from ATN 071 were available for three years of follow-up; blood samples for ATN 101 were collected at the final ATN 071 study visit. In a subset of participants co-enrolled in ATN 061 ("Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/ritonavir (ATV/r) in Adolescents and Young Adults with CD4 + T Cells > 350 cells/mm3 Initiating HAART), biomarkers were evaluated before and after the initiation of HAART. Some biospecimens are available; for inquiries, please contact Dr. John Sleasman (john.sleasman@duke.edu).

DOI: 10.57982/dw3m-r692

Source Repository: DASH

Data Collection Period: 2011-02-15 to 2013-05-15

NICHD Division/Branch/Center: DER - Fertility and Infertility Branch (FIB)

NICHD Research Networks and Initiatives: Reproductive Medicine Network (RMN)

Study Description: In this multicenter, randomized trial published in NEJM, 900 couples with unexplained infertility were enrolled to test the standard therapy of gonadotropin or clomiphene citrate for women with unexplained infertility against ovarian stimulation with letrozole to reduce multiple gestations while maintaining live birth rates. The primary outcome was the rate of multiple gestations among women with clinical pregnancies, and we found that in women with unexplained infertility, ovarian stimulation with letrozole resulted in a significantly lower frequency of multiple gestation but also a lower frequency of live birth, as compared with gonadotropin but not as compared with clomiphene.

DOI: 10.57982/jq4x-e077

Source Repository: DASH

Data Collection Period: 2010-08-15 to 2012-09-30

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: ATN 116 utilized existing Connect to Protect (C2P) coalition infrastructure to address structural barriers hindering the ability of HIV-infected youth to link to care and remain engaged in care, continuing efforts outlined in ATN 095 and ATN 105. Enhanced strategic planning activities assisted coalitions in identifying structural changes to address Linkage-to-Care (LTC), Engagement-in-Care (EIC), and/or Retention-in-Care (RIC) outcomes for newly diagnosed HIV+ youth. ATN 128 extended ATN 116, pairing four Ryan White Part D (RWD) sites with five Adolescent Medicine Trials Units. LTC Coordinators at the paired sites received intensive training in motivational interviewing focused on improving acceptance of LTC services and increasing adherence to HIV-related medical visits. RWD site personnel also joined C2P activities intended to address structural barriers to HIV care. As ATN 128 is a continuation of ATN 116, the files should be analyzed together.

DOI: 10.57982/ezb9-pc07

Source Repository: DASH

Data Collection Period: 2012-10-15 to 2016-05-15

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: YouTHrive (YT) was a two-arm randomized control trial (RCT) that tested the efficacy of an adapted version of the Thrive With Me (TWM) intervention for youth living with HIV (YLWH). In the RCT, intervention participants had access to the full YouTHrive (YT) website- a mobile-enhanced private social networking website aimed at improving medication adherence for YLWH. We enrolled 208 youth (15-24 years old) of all genders living in eight cities and randomized them to either the intervention condition or control condition. Assessments were collected at baseline and month 5 for all participants. Additionally XX participants also were asked to complete assessments at month 8 and month 11.

DOI: 10.57982/v71e-hx81

Source Repository: DASH

Data Collection Period: 2019-07-29 to 2022-05-31

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: The LYNX protocol involved qualitative formative work (aim 1), an open technical pilot (aim 2) to refine the LYNX app, and a pilot randomized controlled trial (RCT) to evaluate acceptability, feasibility, and preliminary efficacy (aim 3) of the LYNX app to increase HIV/STI testing and PrEP uptake among HIV-uninfected young sexual minority men (SMM) aged 15-24. Participants were enrolled at two sites in Chicago, IL and Tampa, FL. Aim 1 was conducted over a 6-month period and included 40 participants; data included focus groups and in-depth interviews. Aim 2 was conducted over a 4 month period and included 15 participants; data included an online exit interview, a computer-assisted self-interview (CASI), and app analytics. Aim 3 was conducted over a 9--month period, and included 60 participants randomized 2:1 to either receive LYNX or standard of care; data included CASI, app analytics, case-report form (CRF) data on study implementation, and in-depth interviews in the LYNX arm. In early testing, participants found most parts of the LYNX app easy to use. Participants found the app most useful in helping them track their sexual partners and motivating them to get tested for HIV and STIs. In the larger pilot study, the app was highly acceptable, with almost all participants using the app at least once -- on average, participants used the app 15 times during the 6 month period. Rates of HIV testing were higher in the group receiving the LYNX app compared with a group receiving usual care. Rates of linkage to PrEP services were similar between the groups.

DOI: 10.57982/frx1-hh59

Source Repository: DASH

Data Collection Period: 2018-10-25 to 2019-12-04

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: Based on extensive formative, community-engaged research and subsequent theater testing and an open technical pilot, we developed a theory-driven mobile app—MyChoices—to increase HIV testing and PrEP uptake among young men who have sex with men (YMSM), ages 15-24. In a pilot randomized controlled trial (RCT), YMSM at risk for HIV acquisition in the US (n=60) were randomized 2:1 to receive MyChoices or standard of care (SOC). Data from 3-month and 6-month post-baseline assessments demonstrate that the app was highly acceptable (System Usability Score; mean=75.8, SD=10.7) and feasible (94% used the MyChoices app at least once; mean=15.3 sessions, SD=9.8). While not powered to assess efficacy, those in the MyChoices arm had 22% higher prevalence of HIV testing over follow-up compared to those in the SOC arm (NS). There was no difference in PrEP uptake.

Source Repository: DASH

Data Collection Period: 2018-11-13 to 2019-11-05

NICHD Division/Branch/Center: DER - Maternal and Pediatric Infectious Disease Branch (MPIDB)

NICHD Research Networks and Initiatives: Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Study Description: COMPARE was part of the iTech NIH U19, which had an overall goal to develop innovative technology-focused interventions addressing the HIV prevention and care continuum for youth. In years 1-2 of the grant, the investigators optimized and pilot tested using a similar study design and identical study outcomes, two distinct mobile apps called LYNX and MyChoices. Each app was designed to increase HIV testing and PrEP uptake among YMSM. In this study, the individual apps were tested in a follow-on research study and evaluated for efficacy. YMSM were randomized to receive either MyChoices, LYNX, or SOC. It included three major functions that were designed to promote self-efficacy, self-regulation, goal-setting and environmental influences to impact behavior change. Compared to standard of care (59%), participants randomized to MyChoices (74%; p=.010) were more likely to have received at least one HIV test over 6 months of follow up; those randomized to LYNX also had higher proportion of testing (70%) but it was marginally statistically different (p=.078). While participants in both MyChoices (21%) and LYNX (20%) arms had higher rates of starting PrEP compared to SOC (16%), these differences were not significant (p=.516). Given the ubiquity of mobile app use and modest resources required to scale this intervention, a 25% relative increase in HIV testing among YSMM, as seen in this study, could facilitate curtailment of the epidemic in the U.S. and even globally.

DOI: 10.57982/vemk-7927

Source Repository: DASH

Data Collection Period: 2019-10-14 to 2022-05-31

NICHD Division/Branch/Center: DER - Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)

NICHD Research Networks and Initiatives: Best Pharmaceuticals for Children Act (BPCA)

Study Description: Ureaplasma (UU) respiratory tract colonization is a risk factor for BPD in preterm infants. We hypothesized that azithromycin (AZM) therapy will prevent BPD in UU-colonized preterms. We conducted a Phase IIb RCT of 20 mg/kg x3d IV AZM in infants 24^0-28^6 wks GA randomly assigned within 4d following birth. The primary efficacy outcome was UU-free survival. Secondary outcomes included mortality, UU clearance, physiologic BPD at 36 wks PMA, and 2 yr corrected age serious respiratory morbidity (SRM) and neurodevelopmental impairment (NDI). 121 randomized infants (AZM, N=60; placebo, N=61) were enrolled. 44(36%) were UU+ (AZM, N=19; placebo, N=25). UU-free survival was 55/60 [92%(95%CI, 82%-97%)] for AZM compared to 37/61 [61%(95%CI, 48%-73%)] for placebo. AZM eradicated UU in all UU+AZM infants, but 21/25(84%) UU+placebo infants remained culture+. There were no significant differences in death/SRM (34.8% vs 30.4%, p=0.67) or death/moderate-severe NDI (47% vs 33%, p=0.11) between AZM and placebo groups at 2 yrs.

DOI: 10.57982/1hc5-jc06

Source Repository: DASH

Data Collection Period: 2013-10-15 to 2018-12-30