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Enteral vitamin A for reducing severity of bronchopulmonary dysplasia in extremely preterm infants: a randomised
Abhijeet Rakshasbhuvankar1,2,3, Sanjay Patole4,5, Karen Simmer4,5
1King Edward Memorial Hospital, 374 Bagot Road, Subiaco, WA, 6008, Australia. abhijeet.rakshasbhuvankar@health.wa.gov.au.
Insights
This study investigates if enteral vitamin A can prevent bronchopulmonary dysplasia (BPD) in preterm infants. Enteral vitamin A may offer a safe and effective alternative to injections for BPD prevention.
Area of Science:
- Neonatal Medicine
- Nutritional Science
- Respiratory Medicine
Background:
- Intramuscular vitamin A reduces bronchopulmonary dysplasia (BPD) risk in very-low-birth-weight infants.
- Intramuscular administration is limited by discomfort and trauma.
- Enteral vitamin A, particularly water-soluble forms, requires further clinical evaluation.
Purpose of the Study:
- To assess the efficacy of enteral water-soluble vitamin A in decreasing BPD severity.
- To compare enteral vitamin A with a placebo in preterm infants.
- To evaluate a potentially simpler, globally acceptable preventive therapy for BPD.
Main Methods:
- Double-blind, randomized, placebo-controlled trial in a tertiary neonatal intensive care unit.
- Inclusion: infants <28 weeks gestational age, <72 hours old; exclusion: major congenital abnormalities.
- Intervention: enteral water-soluble vitamin A (5000 IU/day) or placebo from feed introduction until 34 weeks post-menstrual age (PMA).
Main Results:
- Primary outcome: BPD severity assessed by SpO2-PiO2 curve shift at 36 weeks PMA.
- Sample size: 188 infants for 80% power, 5% significance, expecting 20% reduction in curve shift.
- Secondary outcomes: vitamin A levels, lung/diaphragm function, clinical outcomes, and safety.
Conclusions:
- Enteral vitamin A supplementation offers a promising alternative to intramuscular injections.
- If proven effective and safe, this method could become a standard preventive therapy for BPD.
- This research addresses the significant economic burden of BPD on healthcare systems.
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; ACTRN12616000408482 (30th March 2016).
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