Efficacy Of Expressed Breast Milk In reducing pain during routine Screening Procedure in Pre Term Neonates-A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome is pain intensity as assessed with the PIPP. The score is assessed at baseline (before starting the procedure),during the procedure and at 1 min and 3 min after the procedure. The PIPP scale is a multidimensional measure developed to assess acute pain in preterm and term infants. It measures gestational age, behavioural state, heart rate, oxygen saturation, and three facial reactions (brow bulge, eye squeeze, nasolabial furrow).
研究概览
简要总结
Efficacy of expressed breast milk in reducing pain during routine screening procedure in pre term neonates-a randomised controlled trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Day(s) 至 6.00 Day(s)（—）
- 性别
- All
入选标准
- •All preterm/premature neonates inborn and admitted in NICU / IPD/ well baby,(<37wks,<2500gms) had APGAR scores ⩾7 at 5 minutes; were aged ⩾24 hours; were undergoing venepuncture.
排除标准
- •â–ªAll term neonates â–ªDiagnosed with neurologic problems of any type, if they had received analgesic or sedative drugs within 24 hours of enrolment or neonates having cardio-respiratory compromise, sepsis, central nervous system depression and severe congenital malformations.
结局指标
主要结局
The primary outcome is pain intensity as assessed with the PIPP. The score is assessed at baseline (before starting the procedure),during the procedure and at 1 min and 3 min after the procedure. The PIPP scale is a multidimensional measure developed to assess acute pain in preterm and term infants. It measures gestational age, behavioural state, heart rate, oxygen saturation, and three facial reactions (brow bulge, eye squeeze, nasolabial furrow).
时间窗: The primary outcome is pain intensity as assessed with the PIPP. The score is assessed at baseline (before starting the procedure),during the procedure and at 1 min and 3 min after the procedure. The PIPP scale is a multidimensional measure developed to assess acute pain in preterm and term infants. It measures gestational age, behavioural state, heart rate, oxygen saturation, and three facial reactions (brow bulge, eye squeeze, nasolabial furrow).
次要结局
- Secondary outcomes included crying incidence, percentage of time spent crying during and 3 minutes after lancing, and the incidence of AEs (Eg, nausea, regurgitation, vomiting, choking, de-saturation, tachycardia and bradycardia)(Secondary outcomes included crying incidence, percentage of time spent crying during and 3 minutes after lancing, and the incidence of AEs (Eg, nausea, regurgitation, vomiting, choking, de-saturation, tachycardia and bradycardia).)