A Study on assessing the effect of enteral Docosahexaenoic acid in Retinopathy of prematurity :An open labelled randomised controlled trail
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Proportion of neonates with any stage of Retinopathy of prematurity according to International classification of Retinopathy of prematurity (ICROP) Criteria
研究概览
简要总结
Retinopathy of prematurity (ROP) is a highly prevalent disease in premature neonates and is a leading preventable cause of childhood blindness¹.Extremely preterm birth cuts off the supply of the omega 6 long chain polyunsaturated fatty acid (LC-PUFAs) arachidonic acid and the omega 3 polyunsaturated fatty acids (LC-PUFAs) docosahexaenoic acid (DHA) which exerts pro angiogenic effects in increasing retinal vascularization.Thus the shortage of these LCPUFAs is associated with ROP progression. An Open labelled Randomized Controlled Trial conducted on neonates with gestational age <34weeks/<2kg with age <7days of life after randomization into DHA group or control group.Neonates randomized to DHA group will receive daily dose of 75mg/kg DHA for a period of 4 weeks and Neonates in Control group will not receive any supplementation and will be managed as standard NICU protocol.ROP screening will be done from 2nd week of life till 44 weeks of PMA and looks for development of any stage of ROP.
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 7.00 Day(s)（—）
- 性别
- All
入选标准
- •Neonates with gestational age less than 34 weeks Birth weight less than 2000 grams Age less than 7 days Initiated on enteral feeds Informed and return concern of the parents/guardian.
排除标准
- •Neonates with major congenital malformations Neonates whose mother is on omega 3 supplements.
结局指标
主要结局
Proportion of neonates with any stage of Retinopathy of prematurity according to International classification of Retinopathy of prematurity (ICROP) Criteria
时间窗: 4 weeks after administration of Docosahexaenoic acid
次要结局
- secondary outcome(1.Proportion of neonates with Stage 3 Retinopathy of prematurity)
研究者
Cherukula sahithi
INDIRA GANDHI INSTITUTE OF CHILD HEALTH