Journal article
Should Vitamin A Injections to Prevent Bronchopulmonary Dysplasia or Death Be Reserved for High-Risk Infants? Reanalysis of the National Institute of Child Health and Human Development Neonatal Research Network Randomized Trial
The Journal of pediatrics, Vol.236, pp.78-85.e5
09/2021
DOI: 10.1016/j.jpeds.2021.05.022
PMCID: PMC8403138
PMID: 34004189
Abstract
To determine whether infants at higher risk of bronchopulmonary dysplasia (BPD) or death benefit more from vitamin A therapy than those at lower risk.
We conducted a post hoc reanalysis of a landmark phase III randomized controlled trial conducted from January 1996 to July 1997 at 14 university-affiliated neonatal intensive care units in the US. Data analysis was performed from October 2019 to October 2020. Infants born weighing 401-1000 g and receiving respiratory support at 24 hours of age were assigned to intramuscular vitamin A 5000 IU or sham procedure 3 times weekly for 4 weeks. The primary outcome was BPD, defined as use of supplemental oxygen, or death at 36 weeks postmenstrual age. An externally validated model for predicting BPD or death was used to estimate the risk of these outcomes for each infant.
As previously reported, 222 of 405 infants (54.8%) assigned vitamin A therapy and 248 of 402 infants (61.7%) in the control group developed BPD or died (relative risk [RR], 0.89 [95% CI, 0.80-0.99]; risk difference [RD], -6.9% [95% CI, -13.0 to -0.7]). The predicted individual risks of BPD or death ranged from 7.1% to 98.6% (median, 61.5%; mean, 60.9%). The effect of vitamin A therapy on BPD or death depended on infants' risk of the primary outcome (P = .03 for interaction): for example, a RR of 0.73 (RD, -14.5%) for infants with a 25% predicted risk and a RR of 0.96 (RD, -1.0%) for infants with a 75% risk. There was no difference in the decrease in vitamin A deficiency across risk groups.
Contrary to expectations, the effect of vitamin A therapy on BPD or death was greater for lower risk than higher risk infants.
ClinicalTrials.gov NCT01203488.
Details
- Title: Subtitle
- Should Vitamin A Injections to Prevent Bronchopulmonary Dysplasia or Death Be Reserved for High-Risk Infants? Reanalysis of the National Institute of Child Health and Human Development Neonatal Research Network Randomized Trial
- Creators
- Matthew A Rysavy - University of IowaLei Li - RTI InternationalJon E Tyson - The University of Texas Health Science Center at HoustonErik A Jensen - Children's Hospital of PhiladelphiaAbhik Das - RTI InternationalNamasivayam Ambalavanan - University of Alabama at BirminghamMatthew M Laughon - University of North Carolina at Chapel HillRachel G Greenberg - Duke UniversityRavi M Patel - Emory UniversityClaudia Pedroza - The University of Texas Health Science Center at HoustonEdward F Bell - University of IowaEunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network
- Resource Type
- Journal article
- Publication Details
- The Journal of pediatrics, Vol.236, pp.78-85.e5
- DOI
- 10.1016/j.jpeds.2021.05.022
- PMID
- 34004189
- PMCID
- PMC8403138
- ISSN
- 0022-3476
- eISSN
- 1097-6833
- Grant note
- UG1 HD068244 / NICHD NIH HHS L40 HD099827 / NICHD NIH HHS F32 HD098782 / NICHD NIH HHS UG1 HD040492 / NICHD NIH HHS K24 HL143283 / NHLBI NIH HHS UG1 HD027851 / NICHD NIH HHS UG1 HD087226 / NICHD NIH HHS U24 HD095254 / NICHD NIH HHS UG1 HD087229 / NICHD NIH HHS UG1 HD053109 / NICHD NIH HHS U10 HD021373 / NICHD NIH HHS K23 HL136843 / NHLBI NIH HHS UL1 TR003167 / NCATS NIH HHS UG1 HD034216 / NICHD NIH HHS
- Language
- English
- Date published
- 09/2021
- Academic Unit
- Stead Family Department of Pediatrics; Neonatology
- Record Identifier
- 9984354117702771
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