Efficacy of Expressed Breast Milk Alone or in Combination With Paracetamol in Reducing Pain During ROP Screening
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Decrease in pain
研究概览
简要总结
Efficacy of Expressed Breast Milk Alone or in Combination with Paracetamol in Reducing Pain during ROP Screening.
详细描述
Retinopathy of prematurity (ROP) has been widely acknowledged to be the primary cause of preventable childhood blindness in developing countries. However, the procedure for screening is extremely painful. In this study, we will attempt to relieve the pain experienced by these babies using breast milk alone or in combination with oral paracetamol. This randomized control trial study will be conducted with the aim to assess the efficacy of Expressed Breast Milk Alone or in Combination with Paracetamol in Reducing Pain during ROP Screening. All preterm neonate who undergone ROP screening will be the study population. A total of 60 preterm neonates will be randomized into three groups: (Group A - control group = 20, Group B - breast milk group = 20, and Group C - oral paracetamol + breast milk = 20). Group A will get current care as per institutional protocol, Group B received 2 ml expressed breast milk (EBM) through a sterile syringe orally 2 min prior to procedure, Group C received syrup paracetamol, 15 mg/kg 30 min prior to procedure and EBM as in Group B. Pain experienced was measured by the premature infant pain profile (PIPP) score 20 s prior, during and 2 min after procedure. All procedures were video recorded. The Ophthalmologist and analyzer both will be blinded to the intervention. Results will be incorporated after enrollment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Both investigator and outcome assessor will be blinded.
入排标准
- 年龄范围
- 20 Days 至 2 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age <35 weeks, and birth weight <2000 gm
排除标准
- •Parents of neonate who refused to participate in the study
- •Newborns with multiple congenital anomalies
- •Patient who is on mechanical ventilator during ROP examination
- •Neonate receiving narcotic or sedative drugs
- •Neonate not receiving oral feed.
研究组 & 干预措施
Expressed breast milk
Babies will get only expressed breast milk.
干预措施: Paracetamol (Drug)
paracetamol plus expressed breast milk
Babies will get expressed breast milk plus paracetamol
干预措施: Paracetamol (Drug)
结局指标
主要结局
Decrease in pain
时间窗: 6 months
Premature Infant Pain Score
次要结局
未报告次要终点
研究者
Rumpa Mani Chowdhury
DR
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
