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BMC Pediatrics
Published in: BMC Pediatrics 1/2017

Open Access 01-12-2017 | Study protocol

Enteral vitamin A for reducing severity of bronchopulmonary dysplasia in extremely preterm infants: a randomised controlled trial

Authors: Abhijeet Rakshasbhuvankar, Sanjay Patole, Karen Simmer, J. Jane Pillow

Published in: BMC Pediatrics | Issue 1/2017

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Abstract

Background

Intramuscular vitamin A supplementation decreases the risk of bronchopulmonary dysplasia (BPD) in very-low-birth-weight preterm infants without significant adverse effects. However, intramuscular vitamin A supplementation is not widely accepted because of the discomfort and risk of trauma associated with repeated injections. Enteral vitamin A supplementation has not been studied adequately in the clinical trials. Enterally administered water-soluble vitamin A is absorbed better than the fat-soluble form. We hypothesised that enteral administration of a water-soluble vitamin A preparation will decrease severity of BPD compared with a control group receiving placebo.

Methods

We plan a double-blind randomised placebo-controlled trial at a tertiary neonatal-perinatal intensive care unit. Eligibility criteria include infants born at less than 28 weeks’ gestational age and less than 72 h of life. Infants with major congenital gastrointestinal or respiratory tract abnormalities will be excluded. After parental consent, infants will be randomized to receive either enteral water-soluble vitamin A (5000 IU once a day) or placebo. The intervention will be started within 24 h of introduction of feeds and continued until 34 weeks’ post-menstrual age (PMA).
The primary outcome is severity of BPD at 36 weeks’ PMA. Severity of BPD will be assessed objectively from the right-shift of the peripheral oxyhaemoglobin saturation versus partial pressure of inspired oxygen (SpO2-PiO2) curve. We require 188 infants for 80% power and 5% significance level based on an expected 20% decrease in the right shift of the SpO2-PiO2 curve in the vitamin A group (primary outcome) compared with control group at 36 weeks’ PMA, and a 20% attrition rate.
Secondary outcomes will be plasma and salivary concentrations of vitamin A on day 28 of the trial (first 30 infants), lung and diaphragm function, clinical outcomes at 36 week’ PMA or before discharge/death, and safety of vitamin A.

Discussion

BPD poses a significant economic burden on the health-care system. If our study shows that enteral supplementation of water-soluble vitamin A is safe and effective for decreasing the severity of BPD, it will provide the opportunity to further evaluate a simple, globally acceptable preventive therapy for BPD.

Trial registration

ANZCTR; ACTRN12616000408​482 (30th March 2016).
Appendix
Available only for authorised users
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Metadata
Title
Enteral vitamin A for reducing severity of bronchopulmonary dysplasia in extremely preterm infants: a randomised controlled trial
Authors
Abhijeet Rakshasbhuvankar
Sanjay Patole
Karen Simmer
J. Jane Pillow
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Pediatrics / Issue 1/2017
Electronic ISSN: 1471-2431
DOI
https://doi.org/10.1186/s12887-017-0958-x

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