CTRI/2025/09/095009招募中不适用
Multi-modal stimulation to minimize procedural pain in extremely and very preterm neonates undergoing retinopathy of prematurity: A randomized controlled trial undergoing retinopathy of prematurity
Arunima Anilkumar1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年9月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- PIPP-R (premature infant pain profile revised)
研究概览
简要总结
- Various nonpharmacological interventions have been used to reduce pain in extremely and very preterm neonates undergoing retinopathy of prematurity. This study will be focusing on Multi modal stimulation to reduce pain in preterm infants undergoing ROP. The participants between 28 -32 weeks of gestational age are included in this study.
- Pre-Screening. ROP screening, visual stimulation, auditory stimulation, olfactory stimulation, taste stimulation, and tactile stimulation are given.
- PIPP-R scores are measured before, during, and after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Weight of Less than 1500 grams Gestational age of 28 to 32 weeks Stable neonates Not fed in last 1 hour.
排除标准
- •Any congenital malformations Any congenital infections Babies who are undergoing any corrective surgeries Having any food prohibition Any other neurological conditions History of cardio pulmonary resuscitation or surgery or intraventricular hemorrhage or sedation in last 24 hours Babies requiring positive pressure ventilation Connection to an endotracheal tube.
结局指标
主要结局
PIPP-R (premature infant pain profile revised)
时间窗: 7 times | T0 (30 sec before MMS) | T1 (30 sec after MMS) | T2 (60 sec during ROP examination) | T3 (post 30 sec after ROP examination) | T4 (post 60 sec after ROP examination) | T5 (90 sec after ROP examination) | T6 (post 120 sec after ROP examination)
次要结局
未报告次要终点
研究者
Arunima Anilkumar
Yenepoya Physiotherapy College
研究点 (1)
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