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临床试验/NCT05354479
NCT05354479Unknown4 期

Efficacy of Expressed Breast Milk Alone or in Combination With Paracetamol in Reducing Pain During ROP Screening

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月20日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Babies will get only expressed breast milk.

干预措施: Paracetamol (Drug)

paracetamol plus expressed breast milk

Experimental

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

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rumpa Mani Chowdhury

DR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (1)

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