Journal article
The HYdrocortisone for Bronchopulmonary Dysplasia Respiratory and Developmental (HYBRiD) outcomes study: protocol for a longitudinal cohort study
BMC pediatrics, Vol.24(1), 737
11/14/2024
DOI: 10.1186/s12887-024-05198-9
PMCID: PMC11562334
PMID: 39543521
Abstract
Background
Bronchopulmonary dysplasia (BPD) affects up to half of extremely preterm infants, and is associated with adverse long-term respiratory, neurodevelopmental, and educational sequelae and costly health service and family economic outcomes. The NICHD Neonatal Research Network Hydrocortisone for Bronchopulmonary Dysplasia (BPD) Trial evaluated the efficacy and safety of hydrocortisone treatment to prevent BPD in high-risk infants. The trial enrolled 800 very preterm infants with respiratory failure and followed the participants until 2 years corrected age to assess safety of the trial intervention. Longer-term impacts of hydrocortisone exposure and severity of BPD on functional outcomes of high-risk infants remain unknown. The HYdrocortisone for BPD Respiratory and Developmental (HYBRiD) Outcomes Study extends follow-up of all surviving children enrolled in the Hydrocortisone for BPD Trial until early school age. It aims to characterize the childhood functional motor, cognitive, academic, and pulmonary outcomes of this large, well-phenotyped trial cohort.
Methods
Parents of surviving trial participants complete telephone questionnaires when their children are 3 and 4 years corrected age. A single in-person study visit takes place at early school age (5 years, 0 months to 7 years, 11 months corrected age). Children undergo a multidimensional assessment of functional outcomes and parents complete a battery of questionnaires. In 5 of 19 participating centers, respiratory mechanics are evaluated with impulse oscillometry.
Discussion
The HYBRiD Outcomes Study will be the largest and most comprehensive evaluation to date of the functional early school age outcomes of children with a history of severe neonatal lung disease and of children exposed to HC during infancy. This will substantially improve understanding of the longer-term implications of severe neonatal lung disease; provide data to facilitate the development of future randomized intervention trials in this population; and inform public policy by enhancing knowledge about school age resource requirements in children with a history of prematurity and lung disease.
Trial registration
clinicaltrials.gov ID NCT01353313. Primary trial registration 5/11/11 modified to include followup through school age 12/13/17. This manuscript reflects version 3 of the trial manuscript, dated 10/12/2020.
Details
- Title: Subtitle
- The HYdrocortisone for Bronchopulmonary Dysplasia Respiratory and Developmental (HYBRiD) outcomes study: protocol for a longitudinal cohort study
- Creators
- Sara B. DeMauro - University of PennsylvaniaHaresh Kirpalani - Children's Hospital of PhiladelphiaKristina Ziolkowski - Children's Hospital of PhiladelphiaSusan Hintz - Stanford UniversityKristi Watterberg - University of New MexicoJean Lowe - University of New MexicoSeetha Shankaran - Wayne State UniversitySanjay Chawla - Wayne State UniversityBetty Vohr - Brown UniversityMichael Msall - Comer Children's HospitalCarl D’Angio - University of RochesterBradley A. Yoder - University of UtahKhanh Lai - University of UtahSarah Winter - University of UtahTarah Colaizy - University of IowaStephanie Merhar - Cincinnati Children's Hospital Medical CenterCarla M. Bann - RTI InternationalMarissa Trotta - RTI InternationalJamie Newman - RTI InternationalAruna Natarajan - National Heart Lung and Blood InstituteAbhik Das - National Heart Lung and Blood Institute
- Resource Type
- Journal article
- Publication Details
- BMC pediatrics, Vol.24(1), 737
- Publisher
- BioMed Central
- DOI
- 10.1186/s12887-024-05198-9
- PMID
- 39543521
- PMCID
- PMC11562334
- ISSN
- 1471-2431
- eISSN
- 1471-2431
- Grant note
- National Heart, Lung, and Blood Institute
We are indebted to the children and their families who are taking part in this study. We also gratefully acknowledge the contributions of NHLBI Clinical Trials Specialist Barry Schmetter in the planning of this study.
- Language
- English
- Date published
- 11/14/2024
- Academic Unit
- Stead Family Department of Pediatrics; Neonatology
- Record Identifier
- 9984747077302771
Metrics
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