Effectiveness of reverse kangaroo mother care (rKMC) in reducing pain in neonates during retinopathy of prematurity (ROP) screening- An open labelled randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To determine the
研究概览
简要总结
This study examines reverse Kangaroo Mother Care (rKMC) as an innovative approach to improve ROP screening in preterm neonates by reducing pain, enhancing comfort, and addressing challenges in traditional methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Day(s)（—）
- 性别
- All
入选标准
- •Neonates who require ROP screening under GOI (RBSK 2017) guidelines.
- •Neonates either on room air or non-invasive respiratory support requiring FiO2 less than/equal to 30% at the time of ROP screening.
- •Neonates with weight more than 800 grams at the time of ROP screening regardless of mode of delivery, gestational age, singleton or twin status.
排除标准
- 未提供
结局指标
主要结局
To determine the
时间窗: Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum)
effectiveness of reverse
时间窗: Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum)
KMC in reducing the pain
时间窗: Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum)
during ROP screening
时间窗: Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum)
次要结局
- Compare difference in PIPP-R score(Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum))
- Determine & compare mean change in(Heart rate (HR), SpO2, Respiratory rate)
- Compare number of apnea episodes in rKMC vs Conventional arm(Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum))
- Procedural time difference between both the arms(From insertion of speculum)
研究者
Dr Vijaykumar
AIIMS Bathinda