跳至主要内容
临床试验/CTRI/2025/01/079512
CTRI/2025/01/079512尚未招募不适用

Study Of Ascorbic acid supplementation In reducing morbidities in preterm neonates A Randomized open label Interventional Study

BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2025年2月5日最近更新:

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

发起方
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

M P Sri Hira

BLDE Deemed Shri B M Patil Medical College Hospital and Research Centre

研究点 (1)

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