Effect of Enteral Administration of Docosahexaenoic Acid on Development of the Retinopathy of Prematurity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Presence of retinopathy of prematurity (ROP)
研究概览
简要总结
The purpose of this study is to evaluate whether docosahexaenoic acid given by enteral feeding prevent retinopathy of prematurity and/or diminish its severity in preterm infants.
详细描述
Preterm neonates who start receiving enteral feeding will receive the intervention with docosahexaenoic acid (DHA) since the first day and throughout 14 days, one dose per day.
The opthalmic evaluation will be done after 4-5 weeks after birth and followed until 42-45 corrected gestational age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Minutes 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight < 1500 g
- •Plan to feed by enteral way at a short term
- •Written informed consent, signed by both parents.
排除标准
- •Congenital malformations that avoid enteral feeding
- •immunosuppressor diseases
- •Need for major surgery
- •Persistent bleeding at any level
- •Mother taking n-3 supplements and planning to breastfed
- •Parents who decline the authorization for participating in the study
- •Early discharge to other hospital outside the metropolitan area
结局指标
主要结局
Presence of retinopathy of prematurity (ROP)
时间窗: ROP will be evaluated from 4 to 5 weeks after birth throughout 42-45 of corrected gestational age.
The medical screening to determine the presence ROP will include the exhaustive search of injury on the zone, stage and the presence of plus disease in retina of the preterm infants. The measure unit is frequency of ROP (presence =1 or absence=0) registering the corrected gestational age of the first identification.
次要结局
- Severity of ROP(ROP will be evaluated as changes in each retina's eye from 4 to 5 weeks after birth throughout 42-45 of corrected gestational age)
研究者
Mariela Bernabe García
Full Time Researcher
Coordinación de Investigación en Salud, Mexico