Klemm Rolf D W, Labrique Alain B, Christian Parul, Rashid Mahbubur, Shamim Abu Ahmed, Katz Joanne, Sommer Alfred, West Keith P
DrPH, Johns Hopkins University, Center for Human Nutrition, Department of International Health, Bloomberg School of Public Health, 615 North Wolfe St, Baltimore, MD 21205.
Pediatrics. 2008 Jul;122(1):e242-50. doi: 10.1542/peds.2007-3448.
We assessed the effect of supplementing newborns with 50000 IU of vitamin A on all-cause infant mortality through 24 weeks of age.
This was a community-based, double-masked, cluster-randomized, placebo-controlled trial conducted in 19 unions in rural northwest Bangladesh. The study was nested into and balanced across treatment arms of an ongoing placebo-controlled, weekly maternal vitamin A or beta-carotene supplementation trial. Study-defined sectors (N = 596) were evenly randomized for newborns of participating mothers to receive a single, oral supplement of vitamin A (50000 IU) or placebo as droplets of oil squeezed from a gelatinous capsule. Mothers provided informed consent for newborn participation at approximately 28 weeks' gestation. After birth, typically at home (where >90% of births occurred), infants were supplemented and their vital status was followed through 24 weeks of age. The main outcome measure was mortality through 24 weeks of age.
We obtained maternal consent to dose 17116 live-born infants (99.8% of all eligible) among whom 15937 (93.1%) were visited to be supplemented <30 days after birth and for whom vital status at 24 weeks of age was known. Dosed infants (n = 15902 [99.8%]) received their study supplement at a median age of 7 hours. Relative to control subjects, the risk of death in vitamin A-supplemented infants was 0.85, reflecting a 15% reduction in all-cause mortality. Protective relative risks were indistinguishable by infant gender, gestational age, birth weight, age at dosing, maternal age, parity, or across the 3 treatment arms of the maternal supplementation trial.
Newborn vitamin A dosing improved infant survival through the first 6 months of life in Bangladesh. These results corroborate previous findings from studies in Indonesia and India and provide additional evidence that vitamin A supplementation shortly after birth can reduce infant mortality in South Asia.
我们评估了给新生儿补充50000国际单位维生素A对24周龄以内婴儿全因死亡率的影响。
这是一项在孟加拉国西北部农村地区19个联合乡开展的基于社区的双盲、整群随机、安慰剂对照试验。该研究嵌套于一项正在进行的安慰剂对照、每周给母亲补充维生素A或β-胡萝卜素的试验的各治疗组中,并在各治疗组间保持均衡。将研究定义的区域(N = 596)均匀随机分配,让参与研究的母亲的新生儿接受单次口服维生素A补充剂(50000国际单位)或作为从明胶胶囊中挤出的油滴状的安慰剂。母亲们在妊娠约28周时为新生儿参与研究提供了知情同意。出生后,通常是在家中(超过90%的分娩发生在家中)给婴儿补充,并跟踪其至24周龄时的生命状态。主要结局指标是24周龄以内的死亡率。
我们获得了17116名活产婴儿(占所有符合条件者的99.8%)母亲的给药同意,其中15937名(93.1%)在出生后<30天接受了访视并补充,且已知其24周龄时的生命状态。接受给药的婴儿(n = 15902 [99.8%])接受研究补充剂的中位年龄为7小时。与对照组相比,补充维生素A的婴儿死亡风险为0.85,这反映出全因死亡率降低了15%。按婴儿性别、胎龄、出生体重、给药时年龄、母亲年龄、产次或在母亲补充试验的3个治疗组中,保护性相对风险无差异。
在孟加拉国,给新生儿补充维生素A可提高婴儿出生后头6个月的存活率。这些结果证实了印度尼西亚和印度研究的先前发现,并提供了额外证据,表明出生后不久补充维生素A可降低南亚地区的婴儿死亡率。