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

支气管肺发育不良(BPD)影响多达35%的极低出生体重儿(ELBW；出生体重和体重1000克)。BPD的定义是绝经后36周(PMA)需要补充氧气。这种疾病的特点是呼吸受损，并与高死亡率和严重的长期发病率有关，包括脑瘫。不幸的是，许多治疗方法是无效的(例如，吸入一氧化氮)或有显著的副作用(使用类固醇)。肌注(I.M.)的有益作用补充维生素A(VA)已在最近的Cochrane荟萃分析中得到证实；然而，由于与重复肌注相关的巨大疼痛。注射，这种形式的维生素A补充并不常见。因此，一项随机对照试验(RCT)将评估出生后早期补充大剂量口服维生素A在减少和预防这一易感人群(ELBW婴儿)BPD或死亡中的作用。这项研究(NeoVitaA)的目的是评估出生后早期补充大剂量口服VA与安慰剂28天在预防BPD或ELBW婴儿死亡方面的作用。

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.