VITAMIN A SUPPLEMENTATION FOR EXTREMELY LOW BIRTH WEIGHT INFANTS

极低出生体重婴儿的维生素 A 补充剂

• 批准号: 6290920
• 负责人: JAMES LEMONS
• 金额: $ 1.7万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6290920
• 关键词: clinical research; dietary supplements; dosage; human subject; human therapy evaluation; low birth weight infant human; lung disorder; nutrition related tag; retinoids; vitamin therapy

Although the outcome of extremely low birth weight (ELBW) infants weighing 401-1000 gms has steadily improved over the past 15 years, these infants continue to face a high mortality rate (approximately 25%) and a high incidence of chronic lung disease among survivors (approximately 30%). Evidence from four relatively small clinical trials suggests that vitamin A, or retinol, deficiency in this population may contribute to the severity and incidence of chronic lung disease. The present study is designed to test the hypothesis that Vitamin A supplementation at 2-3 times the recommended routine dose in the ELBW infant will reduce the risk of chronic lung disease and/or death. Most ELBW infants receive intravenous nutrition as their primary energy source for the first 2-3 weeks of life, with about 900 IU vitamin A. When receiving full formula feedings, they generally receive about 900 IU vitamin A per day. However, absorption of either IV vitamin A (which sticks to the IV tubing) or oral vitamin A (which is <50%) is inadequate to meet recommended intakes. This will be a multicenter, randomized, placebo controlled, double-masked prospective trial supported by the National Institute of Child Health and Human Development. Eligible infants will be enrolled between 24 and 96 hours after birth and stratified by birthweight categories (401-750 gms and 751-1000 gms). Within each group, infants will be randomly assigned to treatment (Vitamin A supplementation at greater than routine doses) versus non-treatment or placebo (no extra supplementation provided). Based on an anticipated reduction in death or chronic lung disease of 20%, a total of 780 infants (390 in each group) is required. The study will be performed in the twelve participating newborn intensive care centers of the NIH sponsored Neonatal Network.

尽管极低出生体重（ELBW）婴儿的结果 401-1000 gms 在过去 15 年里稳步改善，这些婴儿 继续面临高死亡率（约25%）和高 幸存者中慢性肺病的发病率（约 30%）。 四项相对较小的临床试验的证据表明，维生素 A（或视黄醇）在该人群中的缺乏可能会导致 慢性肺部疾病的严重程度和发病率。 目前的研究是 旨在检验以下假设：维生素 A 补充量为 2-3 ELBW 婴儿推荐常规剂量的 1 倍将降低风险 慢性肺病和/或死亡。 大多数 ELBW 婴儿接受 静脉营养作为前 2-3 个月的主要能量来源 生命周内，含有约 900 IU 维生素 A。接受全配方奶粉时 喂养时，它们通常每天摄入约 900 IU 维生素 A。 然而， 静脉注射维生素 A（粘在静脉输液管上）或口服吸收 维生素 A（<50%）不足以满足推荐摄入量。 这 将是多中心、随机、安慰剂对照、双盲试验 由国家儿童健康研究所支持的前瞻性试验和 人类发展。符合资格的婴儿将被纳入 24 岁至 96 岁之间 出生后几小时并按出生体重类别分层（401-750 克） 和 751-1000 克）。 在每组中，婴儿将被随机分配 治疗（补充大于常规剂量的维生素 A） 与不治疗或安慰剂（不提供额外补充）相比。 根据预期死亡或慢性肺病减少 20%， 总共需要 780 名婴儿（每组 390 名）。 该研究将是 在十二个参与的新生儿重症监护中心进行 NIH 赞助的新生儿网络。