Study Of Ascorbic acid supplementation In reducing morbidities in preterm neonates A Randomized open label Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Duration of NICU stay
研究概览
简要总结
The wide-ranging health benefits and effects of Ascorbic are well established in adults, along with the tolerable upper intake level (2g/day). However, Vitamin C dosage for preterms with very low birth weight infants as available in the extant literature ranges anywhere between 10-55 mg/kg/day as prescribed by American and European health institutes. There exists limited knowledge on the optimal intake levels along with the role of vitamin C in preterms in reducing associated morbidities like NEC, hyperbilirubinemia, and ROP. Most of the existing literature is also confined to developed countries, where maternal smoking plays a significant role in the plasma ascorbic acid levels of preterm infants, and the findings from such studies may not fully apply to developing countries, such as India necessitating the current study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 20.00 Day(s)(—)
- 性别
- All
入选标准
- •gestational age less than 37 weeks birth weight less than 2.5 kg stable babies on oral or NG tube feeds.
排除标准
- •congenital ,chromosomal anomalies.
- •critically sick babies known inborn errors of metabolism.
结局指标
主要结局
Duration of NICU stay
时间窗: one or two weeks
次要结局
- ROP NEC and IVH RDS(two weeks)
研究者
M P Sri Hira
BLDE Deemed Shri B M Patil Medical College Hospital and Research Centre
