High dose intravenous vitamin A versus lower dose vitamin A supplementation during the first week of life for preventing bronchopulmonary dysplasia (BPD) in extremely-low-birth-weight (ELBW) infants

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Bronchopulmonary dysplasia (BPD) affects as many as 35% of extremely low birth weight infants (ELBW; birth weight < 1000 g). BPD is defined as the need for oxygen supplementation at 36 weeks postmenstrual age (PMA). The disease is marked by respiratory compromise and is associated with high mortality and severe long-term morbidity, including cerebral palsy. Unfortunately, many therapeutic approaches are non-effective (e.g., inhaled nitric oxide) or have significant side effects (administration of steroids). The beneficial role of intramuscular (i.m.) vitamin A (VA) supplementation has been demonstrated in a recent Cochrane meta-analysis; however, because of the substantial pain associated with repetitive i.m. injection, this form of VA supplementation is not common practice. Therefore, a randomized controlled trial (RCT) that will assess the role of early postnatal additional highdose oral VA supplementation to reduce and prevent the occurrence of BPD or death in this susceptible cohort (ELBW infants) is warranted. The aim of this study (NeoVitaA) is to assess the role of early postnatal additional highdose oral VA supplementation versus placebo for 28 days for preventing BPD or death in ELBW infants.