CTRI/2025/07/092071
招募中
不适用
Analgesic effect of breast milk in preterm infants less than 34 weeks undergoing ROP screening _ A randomized control trial
未提供1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年8月18日最近更新:
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Comparison of PIPP-R scores between the two study groups
概览
简要总结
The project title is analgesic effect of breast milk in preterm infants less than 34 weeks undergoing ROP screening which will be an open label randomized control trial single center. The study will be non sponsored study and will be completing in the span of 6 months.
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
- 14.00 Day(s) 至 6.00 Month(s)（—）
- 性别
- All
入选标准
- •All infants less than 34 weeks gestation with birth weight less than 2000 grams (RBSK guidelines).
排除标准
- •Infants on respiratory support Infants who are hemodynamically unstable Infants on drugs causing central nervous depression like sedatives,opioid analgesics or anticonvulsants Infants who are nil by mouth Infants with major/orofacial congenital malformations.
结局指标
主要结局
Comparison of PIPP-R scores between the two study groups
时间窗: Baseline,5 minutes prior to the procedure,immediately after the procedure and 5 minutes after the procedure
次要结局
- Comparison of cry time between the two study groups(During the procedure & 5 minutes after the procedure)
研究者
Dr Anupa Johny Ekka
Lokmanya tilak municipal medical college and general hospital
研究点 (1)
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