A Randomized controlled trial comparing the analgesic effects of expressed breast milk and oral sucrose during single painful procedures in neonates.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To assess the effectiveness of breastmilk in reducing procedural pain in neonates
研究概览
简要总结
This study is a randomized, double blind, parallel group controlled trial comparing the analgesic effects of Breastmilk (Mothers own milk), 24% sucrose solution and a placebo (Sterile water) in healthy newborns undergoing single painful procedures. The primary outcome is to assess he effectiveness of breastmilk in reducing procedural pain in neonates. Secondary outcomes are 1. To compare the analgesic effects of breastmilk, 24% sucrose and a placebo in neonates and 2. To study the variations in physiological parameters (Heart rate, SpO2, Respiratory rate, Mean Arterial Pressure and Mean Crying time) among the three groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •All Clinically Stable Neonates of gestational age 35 weeks and above.
排除标准
- •Perinatal Asphyxia
- •Birth trauma
- •Cardiorespiratory instability, suspected or confirmed sepsis or Necrotising Enterocolitis
- •Any Apparent CNS Anomalies
- •Any Previous surgery
- •Maternal use of opioids, sedatives, analgesics
- •NICU Graduates
- •Consent not obtained
- •Use of Paracetamol or any other analgesics in the baby.
结局指标
主要结局
To assess the effectiveness of breastmilk in reducing procedural pain in neonates
时间窗: at Baseline, 30 seconds post procedure, and 5 minutes post procedure
次要结局
- Comparing the analgesic effects of the three interventions(30 seconds post procedure, 5 minutes post procedure)
- Comparison of changes in NIPS Pain Scores and Physiological Parameters between the three interventions(30 seconds post procedure, 5 minutes post procedure)
研究者
Pranav Agrawal
BGS Global Institute of Medical Sciences