The Effect of Using Breast Milk as a Topical Ophthalmic Drop on Retinopathy of Prematurity. Randomized Placebo-controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Retinopathy of Prematurity
研究概览
简要总结
The aim of this study is to investigate the effect of using breast milk as eye drops on ROP (Retinopathy of prematurity) disease observed in less then 32 weeks gestational age preterm babies.
详细描述
Study Design: Prospective randomized placebo controlled trial Setting/Participants: Premature babies who are at high risk for retinopathy of prematurity (ROP) during their stay in the neonatal intensive care unit (NICU). The study will be carried out at Baskent University and it is planned that 70 participants will be included in the study.
Study Interventions and Measures: After the randomization of the patients, 0.5 ml breast milk of the babies' own mothers will drop on the eye to the intervention group twice a day. IN the control group, %0.9 normal saline will drop as same amount. Primary outcome is any stage of ROP, secondary outcome is severe ROP (laser requiring ROP).
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participant and Ophthalmologist who is the responsible the follow -up the ROP stages will be blind in the study. The neonatologist who is responsible for the care and follow-up of the patients will not be blind.
入排标准
- 年龄范围
- 22 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born between 22 and 32 gestational age weeks or under 1500 gr birth weight.
排除标准
- •Infant death before first examination for ROP
- •parents who want to leave from the study
- •Contraindications for breast milk use (Active HIV infection, Active tuberculosis, CMV infection)
- •Inborn error of metabolism like galactosemia.
- •Congenital eye development disorders like agenesis, or situations that do not allow retina examination.
- •other lethal congenital molformations
- •congenital infections that affect the retina like TORCH infections.
研究组 & 干预措施
Intervention group
With in 48-72 hour after birth, infants will receive 0.5 ml breast milk for own mother as a eye drop twice in a day until the discharge or need for laser coagulation. Fresh milk was used as eye drop ( not exceed 6 hours after milking).
干预措施: Breast milk (Biological)
Placebo group
With in 48-72 hour after birth, infants will receive 0.5 ml 0.9% normal saline as a eye drop twice in a day until the discharge or need for laser coagulation.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Retinopathy of Prematurity
时间窗: by 55 weeks post menstrual age
Number of participants with any stage of ROP
次要结局
- Retinopathy of Prematurity(by 55 weeks post menstrual age)
研究者
Musa Silahli
Principal Investigator
Baskent University