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

生命第一周内高剂量静脉注射维生素 A 与低剂量维生素 A 补充剂预防极低出生体重 (ELBW) 婴儿支气管肺发育不良 (BPD) 的比较

• 批准号: 202087770
• 负责人: Professor Dr. Sascha Meyer
• 金额: --
• 依托单位: Klinik für Allgemeine Pädiatrie und Neonatologie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2012
• 资助国家: 德国
• 起止时间: 2011-12-31 至 2023-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/202087770?language=en
• 关键词: dose; intravenous; vitamin; versus; lower

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.

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< 1000 g）。BPD定义为在月经后36周（PMA）时需要补充氧气。这种疾病的特点是呼吸系统受损，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，吸入的一氧化氮）或具有显著的副作用（施用类固醇）。肌内（i.m.）最近的一项科克伦荟萃分析证实了维生素A（VA）补充剂的有效性;然而，由于与重复i.m.注射，这种形式的VA补充不是常见的做法。因此，有必要进行一项随机对照试验（RCT），评估出生后早期额外口服高剂量VA补充剂对减少和预防该易感队列（ELBW婴儿）发生BPD或死亡的作用。本研究（NeoVitaA）的目的是评估出生后早期额外口服高剂量VA补充剂与安慰剂相比在预防ELBW婴儿BPD或死亡方面的作用。