Evaluation of the Effect of Bovine Colostrum in Prevention of Late Onset Sepsis and Retinopathy of Prematurity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Fundus examination to detect retinopathy of prematurity
研究概览
简要总结
The aim of this study is to evaluate efficacy of bovine colostrum administration as a prophylaxis to decrease the incidence and the occurrence of retinopathy of prematurity in preterm neonates of gestational age less than 32 weeks during their hospital stay.
详细描述
This study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital. Evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (NICU) at Alexandria University Children's Hospital.
The study will be carried out in 4 phases:
- First phase: Enrollment and selection phase.
- Second phase: Intervention phase ( enteral bovine colostrum administration) .
- Third phase: Evaluation phase.
- Fourth phase: collected data analysis and results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Hour 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants ≤ 32 weeks gestational age, weight ≤ 1500 gm. Start feeding in the first 72 hours of life
排除标准
- •Exclusion criteria
- •Patients with any of the following will be excluded:
- •Obvious major congenital abnormalities.
- •Infants expected to be >72 hours of age at the time of randomization.
- •Parental consent lacking/refusal
结局指标
主要结局
Fundus examination to detect retinopathy of prematurity
时间窗: 28 days
ROP screen will be performed by ophthalmologist to detect zone stage extension and severity of the disease
次要结局
- Assessment of weight(28 days)
- -Assessment of Head circumference(28 days)
- prematurity related complications(28 days)
- -Assessment of length(28 days)
研究者
Marwa Mohamed Farag
Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine
Alexandria University