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The HYdrocortisone for Bronchopulmonary Dysplasia Respiratory and Developmental (HYBRiD) outcomes study: protocol for
Sara B DeMauro1,2, Haresh Kirpalani3,4, Kristina Ziolkowski3
1Children's Hospital of Philadelphia, Philadelphia, USA. DeMauro@chop.edu.
Insights
This study follows infants treated for bronchopulmonary dysplasia (BPD) to assess long-term outcomes. It aims to understand the effects of BPD and hydrocortisone on child development up to school age.
Area of Science:
- Neonatal Medicine
- Pediatric Pulmonology
- Developmental Pediatrics
Background:
- Bronchopulmonary dysplasia (BPD) significantly impacts extremely preterm infants, leading to long-term respiratory, neurodevelopmental, and educational challenges.
- The NICHD Neonatal Research Network Hydrocortisone for Bronchopulmonary Dysplasia (BPD) Trial previously assessed hydrocortisone's efficacy and safety in high-risk infants.
- Longer-term impacts of hydrocortisone and BPD severity on functional outcomes remain largely unknown.
Purpose of the Study:
- To extend follow-up of infants from the Hydrocortisone for BPD Trial until early school age.
- To characterize childhood functional motor, cognitive, academic, and pulmonary outcomes.
- To evaluate the long-term effects of hydrocortisone exposure and BPD severity.
Main Methods:
- The HYdrocortisone for BPD Respiratory and Developmental (HYBRiD) Outcomes Study enrolls surviving children from the original trial.
- Parents complete telephone questionnaires at 3 and 4 years corrected age.
- Children undergo an in-person assessment at early school age (5-7 years corrected age), including functional outcome measures and respiratory mechanics (in select centers).
Main Results:
- This study is the largest evaluation of functional school-age outcomes for children with a history of severe neonatal lung disease and hydrocortisone exposure.
- Data collection is ongoing, with findings expected to provide critical insights into long-term developmental trajectories.
- The study will characterize motor, cognitive, academic, and pulmonary function in this cohort.
Conclusions:
- The HYBRiD Outcomes Study will significantly enhance understanding of the long-term implications of severe neonatal lung disease.
- Findings will inform the design of future intervention trials for preterm infants.
- Results will guide public policy regarding resource allocation for children with a history of prematurity and lung disease.
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.
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