Vitamin C supplementation in very preterm infants: a randomised controlled trial
Vitamin C supplementation in very preterm infants: a randomised controlled trial
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DOI：
10.1136/adc.2004.056440
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发表时间：
2005-03-01
影响因子：
4.4
通讯作者：
Winterbourn, CC
中科院分区：
文献类型：
--
作者：
Darlow, BA;Buss, H;Winterbourn, CC
目的：确定调节维生素 C（抗坏血酸：AA）摄入量以达到更高或更低的血浆浓度是否与改善临床结果相关。设计：双盲、随机对照试验。地点：基督城妇女医院新生儿重症监护室。患者：出生体重 < 1500 g 或妊娠 < 32 周的婴儿，在出生 48 小时内入住病房。 干预：婴儿被随机分配到关于生命前 28 天补充 AA 的三种方案之一：ILL 组全程接受低补充； LH 组直到第 10 天都处于低水平，然后很高：HH 组自始至终都处于高水平。 主要结果指标：主要结果指标是经后 28 天和 36 周时的需氧量、补充氧气的总天数和早产儿视网膜病变。在研究开始时（第 2 天）以及第 10 天、第 21 天和第 28 天测量 AA 浓度。 结果：在 24 个月内总共招募了 119 名婴儿（平均妊娠 28.4 周；出生体重 1161 9）。六名婴儿死亡，这些婴儿在随机分组前的 AA 浓度显着高于存活婴儿（116 μmol/l（95% 置信区间 90 至 142）vs 51 μmol/l（45 至 58），p < 0.0001）。各组之间的主要结局没有显着差异。然而，HH 组在月经后 36 周时需要氧气的幸存婴儿比例 (19%) 是 LL 组 (41%) 的一半 (p = 0.06)。结论：在一项随机对照试验中，在生命的前 28 天中，较高或较低的 AA 补充治疗分配没有显着的益处或有害影响。
Objective: To determine whether regulating vitamin C (ascorbic acid: AA) intake to achieve higher or lower plasma concentrations was associated with improved clinical outcome.Design: A double blind, randomised controlled trial.Setting: Neonatal intensive care unit at Christchurch Women's Hospital. Patients: Infants with birth weight < 1500 g or gestation < 32 weeks, admitted to the unit within 48 hours of birth.Intervention: Infants were randomised to one of three protocols with regard to AA supplementation for the first 28 days of life: group ILL received low supplementation throughout; group LH received low until day 10 and then high: group HH received high throughout.Main outcome measures: Primary outcome measures were oxygen requirement at 28 days and 36 weeks postmenstrual age, total days supplemental oxygen, and retinopathy of prematurity. AA concentrations were measured at study entry (day 2), and days 10, 21, and 28.Results: A total of 119 infants were enrolled over 24 months (mean gestation 28.4 weeks; birth weight 1161 9). Six infants died, and these had significantly higher AA concentrations before randomisation than surviving infants (116 mu mol/l (95% confidence interval 90 to 142) v 51 mu mol/l (45 to 58), p < 0.0001). There were no significant differences in primary outcomes between the groups. However, the proportion of surviving infants with an oxygen requirement at 36 weeks postmenstrual age in group HH (19%) was half that in group LL (41%) (p = 0.06).Conclusions: In a randomised controlled trial, no significant benefits or harmful effects were associated with treatment allocation to higher or lower AA supplementation throughout the first 28 days of life.