Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.
Department of Neonatology, All India Institute of Medical Sciences, Rishikesh, India.
Eur J Pediatr. 2019 Aug;178(8):1255-1265. doi: 10.1007/s00431-019-03412-w. Epub 2019 Jun 17.
This randomized double-blind placebo-controlled trial evaluated the effects of early postnatal oral vitamin A supplementation (VAS) in 196 inborn very-low birth weight (VLBW) infants requiring respiratory support at 24 h of age. Eligible infants were randomized to receive aqueous syrup of vitamin A (10,000 IU of retinol/dose; n = 98) or placebo (n = 98) on alternate days for 28 days. Primary outcome variable was composite incidence of all-cause mortality and/or oxygen requirement for 28 days. Secondary outcome variables were safety/tolerability of VAS, serum retinol concentration at recruitment and day 28, duration of oxygen requirement and respiratory support and incidences of complications. On intention-to-treat analysis, composite incidence of all-cause mortality and oxygen requirement for 28 days was significantly lower in vitamin A group (relative risk (95% confidence interval), 0.440 (0.229-0.844); p < 0.05, number needed to benefit, 7). Requirement and duration of oxygen supplementation and non-invasive respiratory support, incidences of late-onset sepsis, patent ductus arteriosus, and duration of hospital stay were also significantly lower in vitamin A group. Serum retinol concentration improved significantly after VAS. No major adverse effect was observed.Conclusions: Early postnatal oral VAS was associated with better composite outcome of all-cause mortality and oxygen requirement without any major adverse effects.Clinical Trial Registration: Clinical Trials Registry of India (CTRI/2017/03/008131). What is Known: • Postnatal intramuscular vitamin A supplementation improves the survival, respiratory outcome and other morbidities in very low birth weight neonates without major adverse effects. • Limited studies on oral vitamin A supplementation did not document substantial benefits. What is New: • Early postnatal alternate-day oral vitamin A supplementation at the dose of 10,000 IU/dose for 28 days improves the composite outcome of death and oxygen requirement in very low birth weight neonates with respiratory distress • No major adverse effects were documented.
这项随机、双盲、安慰剂对照试验评估了在 196 名出生时体重极低（VLBW）且需要在 24 小时内接受呼吸支持的婴儿中早期进行口服维生素 A 补充（VAS）的效果。符合条件的婴儿被随机分为两组，分别接受维生素 A 水溶液糖浆（10000IU 视黄醇/剂量；n=98）或安慰剂（n=98），隔日服用，共 28 天。主要结局变量为全因死亡率和/或 28 天吸氧需求的综合发生率。次要结局变量为 VAS 的安全性/耐受性、招募时和第 28 天的血清视黄醇浓度、吸氧需求和呼吸支持的持续时间以及并发症的发生率。在意向治疗分析中，维生素 A 组的全因死亡率和 28 天吸氧需求的综合发生率显著降低（相对风险（95%置信区间），0.440（0.229-0.844）；p<0.05，需要治疗的人数，7）。VAS 后血清视黄醇浓度显著改善。维生素 A 组的氧气补充和非侵入性呼吸支持的需求和持续时间、晚发性败血症、动脉导管未闭的发生率以及住院时间也显著降低。未观察到主要不良事件。结论：早期进行口服 VAS 可改善全因死亡率和吸氧需求的复合结局，且无任何重大不良影响。临床研究注册：印度临床试验注册处（CTRI/2017/03/008131）。已知：• 肌肉内补充维生素 A 可改善极低出生体重儿的存活率、呼吸结局和其他并发症，且无重大不良影响。• 关于口服维生素 A 补充的有限研究并未证明其有实质性益处。新发现：• 每日 10000IU 剂量，28 天的早期隔日口服维生素 A 补充可改善有呼吸窘迫的极低出生体重儿的死亡和吸氧需求的复合结局。• 未发现重大不良影响。
