Meyer Sascha, Gortner Ludwig
Neonatal Unit, University Hospital of Saarland, Building 9, 66421, Homburg, Germany.
Wien Med Wochenschr. 2017 Sep;167(11-12):264-270. doi: 10.1007/s10354-016-0500-z. Epub 2016 Sep 26.
The aim of the NeoVitaA Trial is to assess the role of postnatal additional high-dose oral vitamin A supplementation for 28 days in reducing Bronchopulmonary dysplasia (BPD) or death in extremely low birth weight (ELBW) infants at 36 weeks postmenstrual age (PMA). All infants (both intervention and control group) will be provided with basic vitamin A (1000 IU/kg/day) in addition to trial intervention.In this short communication, we will give an up-date on obstacles, challenges as well as perspectives and potential solutions when putting into place a multicenter, double-blind, randomized trial in this cohort of extremely susceptible infants.
NeoVitaA试验的目的是评估产后额外补充高剂量口服维生素A 28天对降低极低出生体重（ELBW）婴儿在孕龄36周时支气管肺发育不良（BPD）或死亡的作用。除试验干预措施外，所有婴儿（干预组和对照组）都将补充基本量的维生素A（1000国际单位/千克/天）。在这篇简短的通讯中，我们将介绍在这一极易受影响的婴儿群体中开展一项多中心、双盲、随机试验时遇到的障碍、挑战以及前景和潜在的解决方案。
