CTRI/2023/10/059205已完成3 期
COMPARISON OF EFFECTIVENESS OF CONTINUOUS AND INTERMITTENT PHOTOTHERAPY ON HEALTHY TERM NEONATES WITH HYPERBILIRUBINEMIA - A RANDOMISED CONTROL TRIAL
Uttar Pradesh University of Medical Sciences Saifai Etawah1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年11月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rate of fall of bilirubin in term neonates
研究概览
简要总结
This study is a randomized, single blind, parallel group, active controlled trial comparing the effectiveness of continuous and intermittent phototherapy (3 hours on and 3 hours off cycles) in term neonates with hyperbilirubinemia. The primary outcome measure will be rate of fall of bilirubin. Secondary outcome will be hospital stay and rebound of hyperbilirubinemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 7.00 Day(s)（—）
- 性别
- All
入选标准
- •Babies whose bilirubin level is above the range of pathological hyperbilirubinemia as per American academy of pediatrics nomogram irrespective of cause of hyperbilirubinemia.
- •Term babies who have weight above 2.5kg.
- •Babies less than 7days of life.
- •Both male and female babies are included.
排除标准
- •Parents who are not giving consent for the study.
- •Babies who are having low birth weight and sick babies All term neonates with unstable vitals.
- •Neonates admitted after 7th day of birth.
- •Babies who are having congenital abnormalities.
- •Babies whose total serum bilirubin falling in the exchange transfusion range at the time of admission, requiring NICU admission for any reason other than jaundice.
- •Babies with direct bilirubin >20% of total bilirubin or direct bilirubin >2.0mg/dl Babies who have received prior phototherapy.
结局指标
主要结局
Rate of fall of bilirubin in term neonates
时间窗: After stopping the phototherapy
次要结局
- Hospital stay and rebound hyperbilirubinemia(After stopping the phototherapy)
研究者
研究点 (1)
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