Explore Studies

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 multi-center retrospective chart review of pediatric subjects started on oral baclofen as treatment for spasticity of cerebral palsy (CP). Primary objectives included describing the characteristics of this population and the safety, effectiveness, and treatment course of oral baclofen. Subjects at seven sites with eligible charts were screened to identify 185 subjects who had started on oral baclofen. All 185 subjects had a full chart review and were included in the safety population; and all 185 subjects had documentation in their chart of both a baseline and post-baseline report of effectiveness (Movement/Tone Abnormality assessments), and were included in the efficacy population. Oral baclofen was used to manage spasticity of CP in pediatric subjects who mainly had 4 limb involvement, were on either none or one additional tone medication, and had low gross motor function and manual ability. As shown by the safety analysis, oral baclofen was safe and well tolerated in subjects with severe CP.

DOI: 10.57982/av7d-r684

Source Repository: DASH

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 sub-study of ATN 106 ("Network-Wide Assessment of Current Health Status and Behavioral Risk Factors: An Expanded Study for New Sites in ATN III"). In addition to sharing data collected in ATN 106, an oral rinse sample, the subject’s self reported history and medical chart abstraction of HPV vaccination status and history of oral condylomata, oral dysplasia and oral tumor viruses were collected. Oral rinse specimens were tested for HPV, EBV and KSHV viruses.

DOI: 10.57982/g1d3-2q34

Source Repository: DASH

NICHD Division/Branch/Center: DIR - Division of Intramural Research

NICHD Research Networks and Initiatives: Other Initiatives

Study Description: 2-year cohort study evaluated how stress related changes in the hypothalamic pituitary adrenal axis are associated with changes in linear growth, neurocognitive, and behavioral measures in adopted children. Children adopted from Eastern Europe and Russia and controls (children) were enrolled. Adopted children had significant deficits in growth, cognitive, and developmental measurements compared to controls that improved; however residual deficits remained. Family cohesiveness and expressiveness were protective influences, associated with less behavioral problems, while family conflict and greater emphasis on rules were associated with greater risk for executive dysfunction.

DOI: 10.57982/4tx4-h783

Source Repository: DASH

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: Bleeding and thrombosis represent major adverse events during extracorporeal membrane oxygenation (ECMO). Complications resulting from these events can lead to death or need for long term rehabilitation support. Despite the increasing use of extracorporeal support and new technology which makes it simpler and potentially safer to apply, little scientific information regarding the predictors of bleeding or thrombosis exists. This project sought to describe the incidence of bleeding and thrombosis in ECMO patients at Collaborative Pediatric Critical Care Research Network (CPCCRN) sites and to describe current anticoagulation monitoring practices. Additionally, it sought evidence of association between bleeding and thrombotic complications, laboratory coagulation measurements, patient characteristics, ECMO circuitry, and adherence to center-specific ECMO management protocols. Data was collected on 514 subjects receiving ECMO at CPCCRN sites over a 21-month period.

DOI: 10.57982/95ar-na03

Source Repository: DASH

NICHD Division/Branch/Center: DER - Pediatric Growth and Nutrition Branch (PGNB)

NICHD Research Networks and Initiatives: Bone Mineral Density in Childhood Study (BMDCS)

Study Description: A multi-center, six year longitudinal study examining bone accretion in a racially diverse cohort of 2014 healthy boys and girls ages 5-20 years at 5 clinical centers in the US. The BMDCS cohort included children with height, weight, and body mass index (BMI) between the 3rd and 97th percentile and with no previous or current conditions that might affect bone acquisition. Recruitment occurred in two phases: 1554 subjects ages 6 to 17 years were enrolled during 2002-2003; during 2006-2007 younger (5y) and older (19y) subjects were enrolled to extend the reference percentiles to ages 5-20 years. The second wave of participants were followed for 2 years.  Annual assessments included linear growth, weight gain, pubertal maturation, nutritional status, exercise, bone mineral density (DXA by Hologic) and bone age comprised the main study measures. A subset of patients underwent pQCT and qCT.  The reference curves generated by this carefully executed study are the gold standard for normal bone accrual.

DOI: 10.57982/v8rs-bv08

Source Repository: DASH

NICHD Division/Branch/Center: DIR - Division of Intramural Research

NICHD Research Networks and Initiatives: Other Initiatives

Study Description: The study aims to assess whether interrupting sedentary behavior for 6 consecutive days provides sustained improvements in carbohydrate metabolism without negatively impacting executive function, attention, mood, anxiety, dietary intake, or usual physical activity. If repeatedly interrupting sitting with short activity bouts has sustained beneficial effects among children, interventions examining the frequency, duration, and intensity of such interruptions could be developed for use in the community setting. Thus, these results have the potential to provide insight into novel behavioral intervention targets in youth. This project will investigate if consecutive daily interruption of sitting behaviors improves glucose tolerance, a potential negative health consequences of sedentary behavior in children. Using a randomized parallel group design, children, ages 7-11.99 years, will complete an assigned randomized condition of either 6 consecutive days of 3 hours of monitored sedentary activity (sitting) or 6 consecutive days of 3 hours of interrupted sitting (in which they will be prompted to walk for 3 minutes every 30 minutes). The primary outcome was insulin area under the curve during the oral glucose tolerance test on day 6 during interrupted or uninterrupted sitting. Key secondary outcomes included glucose and c-peptide area under the curve, energy intake at a buffet meal on day 6, and free-living activity assessed using actigraphy. Results are published; see DOI: 10.1111/pedi.13430

DOI: 10.57982/3fsp-ay74

Source Repository: DASH

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 multi-method, prospective study that assessed the transition process of behaviorally-infected HIV-positive youth, aged 18 to 24, as they transitioned from pediatric and adolescent-specific care to adult care. The transition process was characterized from the perspectives of HIV-positive youth, Adolescent Medicine Trials Unit (AMTU) clinic staff, and receiving adult clinic staff. Data on individual psychosocial, behavioral, and clinical factors affecting transition for adolescent and young adult participants were measured through ACASI surveys. Demographic, biomedical, antiretroviral therapy, and healthcare utilization visit information was collected through medical chart abstraction. Information on transition protocols was collected through semi-structured interviews with AMTU and adult clinic staff.

DOI: 10.57982/f1b3-kz10

Source Repository: DASH

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: The CPCCRN Core Data Project (CCDP) obtained descriptive information about all Pediatric Intensive Care Unit (PICU) discharges from the network Clinical Centers, based primarily on Clinical Center hospital administrative databases, and created a database to be used by the CPCCRN investigators and the NICHD. The goal of this project was to provided pilot and descriptive data to CPCCRN investigators so they could use it for hypothesis generation, study design, preliminary power analyses, and recruitment projections for studies under development by the CPCCRN. This dataset includes demographics, severity of illness, admission lengths of stay, diagnoses, discharge disposition and laboratory data. The CCDP was a valuable resource to the CPCCRN and helped stimulate new research protocols, identified potential need for non-network partners to access additional patient populations, and provided a descriptive understanding of the critically ill infants and children cared for within the network.

Source Repository: DASH

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

NICHD Research Networks and Initiatives: Other Initiatives

Study Description: Primary human trophoblasts release a repertoire of extracellular vesicles (EVs). Among them are nano-sized exosomes, which we found to suppress the replication of a wide range of DNA and RNA viruses. We report here our investigation of protein cargo of placental EVs including exosomes, microvesicles, and apoptotic blebs. We isolated EVs using ultracentrifugation and defined their purity using western analysis, electron microscopy, and nanoparticle tracking. We found that trophoblastic exosomes harbor a protein profile that is distinct from that of microvesicles or apoptotic blebs. Functionally, trophoblastic exosomes exhibit the highest anti-viral activity among the EVs. Our work suggests that human trophoblastic EVs may play a key role in maternal-placental-fetal communication.

DOI: 10.57982/dx44-bf61

Source Repository: DASH

NICHD Division/Branch/Center: DER - Child Development and Behavior Branch (CDBB)

NICHD Research Networks and Initiatives: Other Initiatives

Study Description: Two longitudinal studies were conducted for third generation subjects from pedigrees that were either at high risk for developing alcohol use disorders and related substance use disorders or were from control pedigrees. Approximately annual assessment in childhood and adolescence provided information on childhood problems. Interview in young adulthood provided information on substance use disorder outcome as well as other DSM-IV diagnoses.

DOI: 10.57982/qqp0-3z47

Source Repository: DASH

NICHD Division/Branch/Center: DIR - Division of Intramural Research

NICHD Research Networks and Initiatives: Other Initiatives

Study Description: Initially designed as a randomized, double-blind, placebo-controlled clinical trial for children with autism spectrum disorder (ASD), enrollment ceased early due to lack of funding for extramural collaborators. One of the primary aims of the study was to establish the prevalence of hypocholesterolemia and hypercholesterolemia in idiopathic ASD. Available in DASH are laboratory results collected at multiple time points, including cholesterol levels, on 42 children enrolled during the first three years of the study

DOI: 10.57982/pcb0-an70

Source Repository: DASH

NICHD Division/Branch/Center: DIR - Division of Intramural Research

NICHD Research Networks and Initiatives: Other Initiatives

Study Description: Alpha-mannosidosis (AMD) is an inherited lysosomal storage disorder caused by mutations in the LAMAN gene, which encodes lysosomal alpha-mannosidase and is characterized by neurodevelopmental delay, mild immune deficiency, facial and skeletal abnormalities, hearing impairment, intellectual disability, muscle weakness and ataxia. Neuromuscular and skeletal deterioration progresses over decades, rendering most patients wheel-chair dependent. No consistently successful treatment is available. To better characterize the biochemical phenotype and natural history of this disorder, patients with AMD were recruited, ranging in age from five to 60 years, mainly in the US and Canada. Participants in the study visited the NIH Clinical Center for 2-3 days during which they underwent clinical and biochemical evaluations to establish reliable clinical benchmarks and to identify cerebrospinal fluid biomarkers that could serve as candidate surrogate markers of treatment effect in future clinical trials.

DOI: 10.57982/96b0-4n94

Source Repository: DASH

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

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

Study Description: A randomized, double-blind, placebo-controlled trial to evaluate the effectiveness of daily low-dose aspirin in preventing preeclampsia in nulliparous women who begin treatment at 13 to 25 weeks gestation

DOI: 10.57982/52w7-1t05

Source Repository: DASH

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

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

Study Description: A randomized, double-blind, placebo-controlled trial to examine whether daily administration of 60 mg of aspirin beginning at 13 to 26 weeks gestation will decrease the incidence of preeclampsia in pregnant women at high risk for developing the disease. High risk women enrolled were those with chronic hypertension, insulin-dependent diabetes, past history of preeclampsia, or multifetal pregnancy.

DOI: 10.57982/76e6-fj68

Source Repository: DASH

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 study in three phases that examined clinician behaviors with regard to recommending and prescribing pre-exposure prophylaxis (PrEP) as a primary HIV prevention strategy, and to identify knowledge-related and attitudinal factors associated with these behaviors. Through three phases, researchers used semi-structured interviews with ATN-affiliated clinicians to develop a new theory-based survey instrument, and administered the newly developed survey to clinicians. The primary objectives were to explore clinician attitudes and prescribing behaviors of PrEP for men who have sex with men (MSM) and heterosexually active adults and adolescents, and to identify factors associated with prescribing PrEP.

DOI: 10.57982/hcjc-c673

Source Repository: DASH

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

NICHD Research Networks and Initiatives: Collaborative Home Infant Monitoring Evaluation (CHIME)

Study Description: Infants were enrolled into four groups: healthy term, preterm infants <1750g w/o significant morbidity, sibling of SIDS, and babies experiencing apparent life-threatening events. Objectives were to: determine monitor efficacy in identifying episodes endangering the infant's health; determine conditions optimizing use of apnea monitors in high risk infants; correlate physiological markers with the propensity for life-threatening events; and report on maturation of heart and respiratory function in sleeping infants. Data were collected from nightly home recordings (via CHIME Monitor device) and one sleep lab polysomnography (PSG) session (via CHIME Monitor and ALICE3 devices). CRF data include sociodemographic and medical information on mother and infant at entry and from scheduled medical follow-up visits through 1-year of age, weekly phone calls, monitor knowledge and satisfaction scales, periodic assessments with the Bayley II, NCAST, subscales of the Parenting Stress Index, and hospitalizations.

DOI: 10.57982/v5av-dn69

Source Repository: DASH

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

NICHD Research Networks and Initiatives: Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings (PATC3H)

Study Description: The purpose of this study was to gather data to describe the demographic, biomedical, psychosocial, and behavioral characteristics of adolescents and young adults living with HIV (AYAHIV) in Nampula, Mozambique, to inform content of the multicomponent CombinADO intervention strategy, and to pilot measures for their social contextual relevance and comprehension by participants. A convenience sample of AYAHIV and a subset of their caregivers were recruited from three government health facilities in 2019 in Nampula, Mozambique. AYAHIV 15-19 years on antiretroviral therapy (ART), including females attending antenatal care, were eligible. A total of 212 AYAHIV (15-19 years) were enrolled. All participants completed a one-time quantitative survey that included questions related to sociodemographic characteristics, educational status, health history, sexual and reproductive health, and ART adherence. Routine HIV care data were extracted from medical charts.

DOI: 10.57982/qy0s-8t38

Source Repository: DASH

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

NICHD Research Networks and Initiatives: Community Child Health Research Network (CCHN)

Study Description: A five-year, multi-site, prospective cohort study about stress and resilience and their influence on maternal allostatic load as a mediator of birth outcomes and child health and development. A limited number/types of biospecimens have been collected by the study investigators. For biospecimen availability, please contact the following investigators: Chris Dunkel Schetter (dunkel@psych.ucla.edu); Madeleine Shalowitz (Madeleine.Shalowitz@gmail.com); Calvin J. Hobel (Calvin.Hobel@cshs.org); Vernon M. Chinchilli (vchinchi@phs.psu.edu).

DOI: 10.57982/jwkz-pe51

Source Repository: DASH

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 two-phase study with the primary objective of adapting and piloting Motivational Enhancement System for Adherence (MESA), a brief, two-session, computer-based motivational intervention to prevent adherence difficulties among youth newly recommended to begin HAART. Phase I pre-tested the feasibility and acceptability of the beta version of MESA with Motivational Enhancement System for Health (MESH), a nutrition and exercise control intervention. Following analysis of Phase I responses and further modification of the intervention, Phase II (a pilot randomized controlled trial) was initiated. Phase II tested a two-session MESA intervention, as well as MESH (the attention control), matched for dose and delivery format.

DOI: 10.57982/c10w-nq30

Source Repository: DASH

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: Phase II of a three stage project to develop community-based HIV prevention interventions and form and maintain the necessary community collaborations to support ATN research activities. Phase II described specific locations or venues within high-risk areas where youth spent time. HIV risk behaviors, prevalence, and social networking patterns among youth at these venues were assessed. At a series of meetings, the researcher-community partners established in Phase I discussed Connect 2 Protect (C2P) findings and shared input on recruitment venues, strategies, and other relevant topics. Primary objectives of the study were to identify specific community venues where at-risk youth could be recruited for interventions within the high-risk areas identified in Phase I; describe HIV risk behaviors, social networks, and HIV seroprevalence of adolescents and young adults recruited from targeted venues; and assess the characteristics, quality, and outcomes of the community-researcher partnerships.

DOI: 10.57982/27g4-6e67

Source Repository: DASH

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: Connect to Protect (C2P): Partnerships for Youth Prevention Interventions was a multi-site, three-phase project with the goal of reducing HIV incidence and prevalence among youth through a community mobilization intervention. The objective of ATN 040 (Part One of Phase III) was to initiate and complete an intervention that consisted of guiding C2P coalitions through a strategic planning process resulting in the development and implementation of a local action plan. The action plan focus was to change structural elements of affected communities believed to be associated with youth HIV acquisition and transmission. Each coalition's plan included: (1) identification of potential community structural changes and specific steps for how to effect such changes; and (2) selection of community-level Centers for Disease Control and Prevention (CDC)-endorsed HIV prevention program. This study is a component of other ATN phased studies. Please refer to the protocol for information regarding the other phases.

DOI: 10.57982/z91s-j315

Source Repository: DASH

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: Connect to Protect (C2P): Partnerships for Youth Prevention Interventions was a multi-site, three-phase project with the overall goal of ultimately reducing HIV incidence and prevalence among youth through a community mobilization intervention. In Phase III of C2P (ATN 040) a community mobilization intervention that consisted of guiding C2P coalitions through a strategic planning process for the development and implementation of a local action plan was initiated and completed. As the evaluation sub-study of ATN 040, ATN 040b measured changes In HIV-related risk among high-risk youth at congregation venues, i.e., locations identified by youth, community partners, and C2P site staff as places where members of the population of focus "hang out." This study is a sub-study of another ATN study or studies. Please refer to the protocol for information regarding ATN study connections.

DOI: 10.57982/a9q1-4789

Source Repository: DASH

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 sought to implement Connect to Protect (C2P), a community mobilization intervention intended to develop coalitions to plan for and bring about structural changes to reduce HIV incidence and prevalence among youth in targeted communities. A key aspect of the C2P approach was planning for sustainability beyond the ATN investment. The evaluation of C2P included both process evaluation of the mobilization efforts and outcome evaluation of the changes in individual risk factors associated with HIV transmission and acquisition. The study included extant data collection and mapping, collection of epidemiological HIV/STI data as well as HIV testing data, and key informant interviews.

DOI: 10.57982/5mse-ms56

Source Repository: DASH

NICHD Division/Branch/Center: DiPHR - Division of Population Health Research

NICHD Research Networks and Initiatives: Other Initiatives

Study Description: Collected detailed information from electronic medical records for 228,438 deliveries in 19 U.S. hospitals. Primary objectives were to explore the underlying causes of the high cesarean rate in the U.S. population, describe contemporary labor progression at the national level, and determine when is the more appropriate time to perform a cesarean delivery in women with labor protraction and arrest. NOTE: Data requesters should refer to the "CSL Read Me" PDF describing data caveats.

DOI: 10.57982/821t-ff93

Source Repository: DASH

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

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

Study Description: The goals of this trial are to compare the use of loperamide to oral placebo and to compare the use of anal sphincter exercise training with biofeedback to usual care (educational pamphlet) in the treatment of women suffering from fecal incontinence (FI). We will test the following null hypotheses: there is no difference in outcomes between women randomized to loperamide and women randomized to oral placebo for treatment of FI; there is no difference in outcomes between women randomized to anal sphincter exercises with biofeedback and women randomized to usual care (educational pamphlet) for FI treatment; there is no difference between women randomized to both treatments together and women randomized to either FI treatment alone; and there is no correlation between anal manometry measurements and digital anal squeeze strength or measures of FI severity and bother.

DOI: 10.57982/rnts-2x43

Source Repository: DASH

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 laboratory-based evaluation of cellular immune response to immunization with hepatitis B surface antigen in HIV-infected and HIV-uninfected adolescents. This sub-study of ATN 024 and ATN 025 compared cellular immune response in responders and non-responders to immunization and evaluated the relationship of these factors to the persistence of known correlates of serologic protection for the hepatitis B virus.

DOI: 10.57982/hfy2-zz97

Source Repository: DASH

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: Cortisol Quantification Investigation (CQI) was a prospective, observational cohort study that assessed total and free serum cortisol concentrations in a convenience sample of critically ill children exhibiting a spectrum of illness severity. The goal was to determine whether plasma ultrafiltration can be used in place of equilibrium dialysis by comparing the measured free cortisol following each fractionation method. Site- and patient-level identifiers have been removed from or masked in the public use dataset.

Source Repository: DASH

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: A retrospective study was conducted across the 8 children’s hospitals affiliated with the NICHD CPCCRN. All children between 1 and 18 years of age with critical asthma admitted to a PICU between January 1, 2005 and December 31, 2009 who required intubation and mechanical ventilation or who died were included. Critical asthma is defined as an acute exacerbation of asthma or status asthmaticus as the primary cause for PICU admission. Patients with cystic fibrosis or bronchiolitis were excluded. If a patient was admitted to the hospital more than once during the study period, each hospitalization for critical asthma in which the patient was intubated and mechanically ventilated was included as a case. If a patient was admitted to the PICU more than once during the same hospitalization, only the first PICU admission in which the patient was intubated and mechanically ventilated was included. The study was approved and waiver of informed consent granted by the Institutional Review Board at each site.

DOI: 10.57982/4fvt-6984

Source Repository: DASH

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: The purpose of the FSS (Functional Status Scale) study was to create a functional status outcome measure for large outcome studies that is well defined, quantitative, rapid, reliable, minimally dependent on subjective assessments, and applicable to hospitalized pediatric patients across a wide range of ages and inpatient environments. This study was designed with the intention that FSS would be used throughout the world of pediatric medicine as an assessment tool. FSS domains of functioning included mental status, sensory functioning, communication, motor functioning, feeding, and respiratory status, categorized from normal (score=1) to very severe dysfunction (score=5). The Adaptive Behavior Assessment System II (ABAS II) established construct validity and calibration within domains. Primary care nurses completed the ABAS II.

DOI: 10.57982/aktm-zb15

Source Repository: DASH

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 conducted formative research to develop a culturally appropriate secondary prevention intervention for HIV-positive black young men who have sex with men (B-YMSM). At two AMTU sites, a total of four focus groups guided the selection of the intervention content areas and the development of the intervention manual. The intervention aimed to address increasing engagement in HIV treatment, improving medication adherence, reducing sexual risk behaviors, reducing substance use behaviors, and increasing HIV status disclosure.

DOI: 10.57982/qf66-6w16

Source Repository: DASH

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

NICHD Research Networks and Initiatives: Neonatal Research Network

Study Description: This was a time-limited prospective observational study of all infants born at a NRN center between 23 and 26 weeks gestational age. All clinical decisions made for these babies were at the discretion of the attending neonatologist/infant care team according to standard practice at each institution. Data were collected on blood pressure management in the first 24 postnatal hours for each infant.

DOI: 10.57982/dqeq-xm59

Source Repository: DASH

NICHD Division/Branch/Center: DIR - Division of Intramural Research

NICHD Research Networks and Initiatives: Other Initiatives

Study Description: This study evaluated the safety and efficacy of daily subcutaneous Copper Histidine (CuHis) injections given over three years to impact the neurodevelopmental outcomes in infants with Menkes disease. The impact of early (beginning within 1 month of birth corrected for prematurity) versus late CuHis treatment (beginning beyond 1 month of age and after onset of neurological symptoms) was evaluated.

DOI: 10.57982/x64h-gx77

Source Repository: DASH

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

NICHD Research Networks and Initiatives: Neonatal Research Network

Study Description: This observational study was a surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis. The purpose of the study was to establish current hospital-based rates of EOS among term and preterm infants in the era of intrapartum antibiotic prophylaxis; monitor the organisms associated with EOS and meningitis; compare asymptomatic and symptomatic infants by gestational age and pathogen; and monitor sepsis-associated mortality rates by pathogen group.

DOI: 10.57982/gnnr-qv11

Source Repository: DASH

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

NICHD Research Networks and Initiatives: Neonatal Research Network

Study Description: The primary purpose of this study was to determine rates of early-onset neonatal infection in term and preterm infants in the era of maternal intrapartum antibiotic prophylaxis to prevent vertical transmission of group B streptococcal disease. Early-onset infection comprises early-onset sepsis (EOS) and/or early-onset meningitis (EOM) and is defined as isolation of a pathogen from blood or cerebrospinal fluid (CSF) obtained within 72 hours of birth and provision of appropriate antibiotic treatment for 5 or more days (or <5 days if death occurs while receiving antibiotic therapy). The antimicrobial susceptibility patterns of organisms associated with EOS and EOM were evaluated. Case controls were also identified.

DOI: 10.57982/gmyg-nz51

Source Repository: DASH

NICHD Division/Branch/Center: N/A

NICHD Research Networks and Initiatives: ECHO: IDeA States Pediatric Clinical Trials Network

Study Description: ESC-NOW was a cluster-randomized, controlled trial conducted at 26 U.S. hospitals, which enrolled 1305 infants with neonatal opioid withdrawal syndrome (NOWS). At a randomly assigned time, participants transitioned from usual care based on the Finnegan Neonatal Abstinence Scoring Tool (FNAST) to the Eat, Sleep, Console (ESC) approach. The primary outcome was the time from birth until medical readiness for discharge as defined by the trial. The Eat, Sleep, Console care approach significantly decreased the number of days until infants born with NOWS were medically ready for discharge, without increasing specified adverse outcomes.

Source Repository: DASH

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

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

Study Description: The overall objective of this study is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of Mixed Urinary Incontinence (MUI) symptoms.

DOI: 10.57982/ksnn-d514

Source Repository: DASH

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

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

Study Description: Urinary incontinence is a condition that markedly impacts quality of life. Conservative first line treatments for urge incontinence combined with other overactive bladder (OAB) symptoms include behavioral therapy, pelvic floor training +/- biofeedback, or the use of anticholinergic medications. These treatment modalities may not result in total continence and are often not sustained for various reasons. Thus, the objective of the Anticholinergic versus Botox Comparison Study (ABC) was to determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more effective than a standardized regimen of oral anticholinergics in reducing urge urinary incontinence (UUI). Oral anticholinergic therapy and Botox A® by injection were associated with similar reductions in the frequency of daily episodes of UUI. The group receiving Botox A® was less likely to have dry mouth and more likely to have complete resolution of UUI but had higher rates of transient urinary retention and urinary tract infections.

DOI: 10.57982/xzp0-tr80

Source Repository: DASH

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 sought to continue Connect to Protect (C2P) community mobilization efforts focused on developing coalitions to plan for and bring about structural changes aimed at reducing HIV incidence and prevalence among youth in targeted communities. The extent to which C2P activities influenced elements of the community affecting HIV-related risk prevention, testing, treatment, and linkage to healthcare among youth aged 12 to 24 was assessed. Enhanced strategic planning activities were designed to assist coalitions in identifying necessary and relevant structural changes, and investigators examined how attributes of the structural change objectives related to intermediate outcomes. Evaluation of C2P efforts included both process evaluation of the mobilization efforts and outcome evaluation of the changes in individual risk factors associated with HIV transmission and acquisition.

DOI: 10.57982/7ka4-x689

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: TAP02 objectives were to obtain anthropometric data to allow modification of the Mercy Method and Mercy TAPE to develop the babyTAPE for weight estimation in newborns and young infants. A total of 2097 infants were enrolled at eight sites, stratified to include a cross-section of newborn ages and sizes including preterm. Singular length and girth surrogates correlating most closely with weight were identified and a mathematical model for weight estimation in this population was developed and internally validated. Head circumference and chest circumference demonstrated the best correlations with weight and length and were among the most reproducible as reflected by intraclass correlation coefficients. The final model predicted weight within 10% and 15% of actual for 84% and 94% of infants, respectively, without bias for age measures or sex. No adverse device events were reported.

DOI: 10.57982/3q4x-7p11

Source Repository: DASH

NICHD Division/Branch/Center: N/A

NICHD Research Networks and Initiatives: Other Initiatives

Study Description: The National Institutes of Health launched the Environmental influences on Child Health Outcomes (ECHO) initiative in September 2016. The Program focuses on five pediatric outcome areas: obesity, neurodevelopment, upper and lower airways, pre-, peri-, and postnatal outcomes, and positive health. The ECHO-wide Cohort Study incorporates longitudinal data on a growing 30,000 pregnancies and 50,000 children from 69 pediatric cohorts to investigate how exposure to environmental factors — including physical, chemical, biological, social, behavioral, natural, and built environments — impact child health and development. By bringing data together into one large ECHO-wide Cohort, scientists can address questions that no single cohort, or a few working together, can answer. Most of the cohorts existed prior to ECHO, bringing a wealth of extant data for compilation and harmonization, in addition to standardized collection of new essential and recommended data elements. Data available in DASH are based on an August 31, 2021 data lock.

DOI: 10.57982/ng1v-pz07

Source Repository: DASH

NICHD Division/Branch/Center: N/A

NICHD Research Networks and Initiatives: Other Initiatives

Study Description: The National Institutes of Health launched the Environmental influences on Child Health Outcomes (ECHO) initiative in September 2016. The Program focuses on five pediatric outcome areas: obesity, neurodevelopment, upper and lower airways, pre-, peri-, and postnatal outcomes, and positive health. The ECHO-wide Cohort Study, presented here, incorporates longitudinal data on a growing 30,000 pregnancies and 50,000 children from 69 pediatric cohorts to investigate how exposure to environmental factors — including physical, chemical, biological, social, behavioral, natural, and built environments — impact child health and development. By bringing data together into one large ECHO-wide Cohort, scientists can address questions that no single cohort, or a few working together, can answer. Most of the cohorts existed prior to ECHO, bringing a wealth of extant data for compilation and harmonization, in addition to standardized collection of new essential and recommended data elements.

DOI: 10.57982/bg8s-9535

Source Repository: DASH

NICHD Division/Branch/Center: N/A

NICHD Research Networks and Initiatives: Other Initiatives

Study Description: The National Institutes of Health launched the Environmental influences on Child Health Outcomes (ECHO) initiative in September 2016. The Program focuses on five pediatric outcome areas: obesity, neurodevelopment, upper and lower airways, pre-, peri-, and postnatal outcomes, and positive health. The ECHO-wide Cohort Study, presented here, incorporates longitudinal data on a growing 30,000 pregnancies and 50,000 children from 69 pediatric cohorts to investigate how exposure to environmental factors — including physical, chemical, biological, social, behavioral, natural, and built environments — impact child health and development. By bringing data together into one large ECHO-wide Cohort, scientists can address questions that no single cohort, or a few working together, can answer. Most of the cohorts existed prior to ECHO, bringing a wealth of extant data for compilation and harmonization, in addition to standardized collection of new essential and recommended data elements. This is the third release of the public use data from the ECHO Cohort Study. This release includes shareable data from all eligible participants at the end of the first funding cycle and retains the data from participants in previous releases if the participant is eligible to share data in this release.

DOI: 10.57982/t4gp-vy38

Source Repository: DASH

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: Neonatal deaths now account for over 40% of the under 5 years old deaths. The primary objective of the HBB study was to evaluate the impact of implementing an integrated package of neonatal resuscitation training and equipment among health facility birth attendants in three Global Network sites: Belgaum (India), Eldoret (Kenya), and Nagpur (India). The primary hypothesis evaluated that HBB training materials resulted in a 20% reduction in the observed rate of overall perinatal mortality among births of ≥1500g, pre- versus post-implementation in the participating clusters served by these facilities. The total cohort of 835 active Birth Attendees (BAs) trained and retrained in the HBB curriculum in 71 facilities in India and Kenya showed the lack of resuscitation training was evident by a large initial knowledge-skills gap among the BAs: at the initial HBB training, 74% of BAs passed the pre-training knowledge assessment but only 5% were able to demonstrate effective ventilation of the neonatal mannequin.

DOI: 10.57982/m3kt-4m26

Source Repository: DASH

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 026 investigated the association between HLA class I genotypes and differing HIV-1 disease progression. The study assessed HIV-1 specific CD8+ T-cell responses and the dominant HIV-1 genotype among individuals identified as HLA-B*27, B*35, B*53, and B*57 positive. Participants were followed for two years with medical history, physical exam, and blood sample collection performed every six months. All participants were previously enrolled in REACH, a 5-year longitudinal adolescent study. Some biospecimens are available; for inquiries, please contact Dr. Paul Goepfert (pgoepfert@uabmc.edu).

DOI: 10.57982/sjg5-ap19

Source Repository: DASH

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 determined program-level factors associated with the effectiveness of SMILE in CARING for YOUTH Linkage-to-Care (LTC) program networks at 15 Adolescent Medicine Trial Units (AMTUs). The various LTC programs at the AMTUs were evaluated and categorized. The study then examined associations between LTC program characteristics (providers, practices, and systems) and the proportion of Human Immunodeficiency Virus (HIV)-infected youth, ages 12-24 years old, inclusive, linked to care and maintained in care. This study focused on LTC programs at the AMTUs as the unit of analysis and not the youth themselves.

DOI: 10.57982/5ede-a454

Source Repository: DASH

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

NICHD Research Networks and Initiatives: Neonatal Research Network

Study Description: This study was a randomized, controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with hypoxic-ischemic encephalopathy will reduce the incidence of death or disability at 18-22 months of age.

DOI: 10.57982/hs6z-4j46

Source Repository: DASH

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, preliminary proof of concept study evaluating two types of supplemental information that would serve as an adjunct to the traditional informed consent in an HIV vaccine clinical trial. Participants were administered a standard HIV vaccine trial consent form and were then randomized into three conditions: no supplemental information provided, supplemental information with 1-sided messages provided, and supplemental information with 2-sided messages provided. Interviewers administered Part 1 of a two-part questionnaire before the informed consent was reviewed with participants. Part 2 of the questionnaire was administered either directly after the informed consent in the control condition, or after participants read through supplemental materials in the other two conditions. A debriefing interview was conducted with selected participants to review their understanding of the study procedures and reactions to the supplemental materials and/or questionnaires.

DOI: 10.57982/peg2-rr82

Source Repository: DASH

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 extends the follow-up of women in the OPTIMAL study, a randomized trial to compare sacrospinous ligament fixation (SSLF) to uterosacral ligament suspension (ULS), and to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence (SUI). The primary aims are to compare SSLF and ULS for the following outcomes up to 5 years after surgery in women with Stage 2-4 prolapse involving the vaginal apex or uterus and SUI: time to surgical failure; the long-term functional and health-related quality of life, adjusted for PMT treatment group; the annual and cumulative incidence, resolution, and persistence of pelvic floor symptoms, adjusted for PMT treatment group; and determine whether exposure to a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process will improve enrollment and/or retention.

DOI: 10.57982/0p9k-rf96

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: This was a retrospective observational chart review to determine the incidence of events of special interest for hospitalized, extremely low birth weight infants admitted to one of two neonatal intensive care units and exposed to furosemide or bumetanide. The trial enrolled 679 infants, with 521 receiving furosemide treatment; 166 of these infants received bumetanide in addition to furosemide (no infants received bumetanide only). There were profound dosing differences between the two sites. Infants administered furosemide tended to be sicker than infants not administered furosemide at both sites. No association between diuretic use and death was found. Increased drug exposure was associated with higher rates of bronchopulmonary dysplasia diagnosis. Rates of hearing loss, cerebral palsy diagnosis, and abnormal Bayley scores were low (<15%) at each site. Rates of both hearing loss and kidney stones differed between sites.

DOI: 10.57982/y5cz-pp38

Source Repository: DASH

NICHD Division/Branch/Center: NCMRR - National Center for Medical Rehabilitation Research

NICHD Research Networks and Initiatives: Medical Rehabilitation Research Resource Network (MR3 Network)

Study Description: The first national, randomized, single-blind study to systematically test a neurorehabilitation therapy - constraint induced movement therapy (CIMT) - among patients with the ability to initiate extension movements at the wrist and fingers and who had experienced a first stroke within 3 to 9 months prior to enrollment. Participants recruited from 247 clinics nationwide were randomized to receive CIMT to the more impaired upper extremity for two weeks upon enrollment or to receive the identical intervention 15-21 months post-stroke. Outcome measures were the Wolf Motor Function Test (WMFT) and Motor Activity Log (MAL) for functional improvements and the Stroke Impact Scale (SIS) for health-related quality of life.

DOI: 10.57982/wvcy-5c96

Source Repository: DASH