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临床试验/NCT03740594
NCT03740594已完成不适用

Effect of Kangaroo Mother Care and Its Duration on Neurobehavioral Performance and Stress Response of Preterm Neonates

Ain Shams University0 个研究点目标入组 120 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
主要终点
Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)

研究概览

简要总结

This prospective cohort study was conducted on stable preterm infants (31 to 35 weeks gestation). Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days. Neonates were evaluated by Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) at 36 weeks gestation. Salivary cortisol was measured before and after first KMC session and after 7 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Stable preterm neonates with gestational age between 31 and 35 weeks.

排除标准

  • Neonates with major congenital birth defects or chromosomal anomalies.
  • Perinatal asphyxia and intra-ventricular hemorrhage.
  • Hemodynamically significant cardiac abnormalities.
  • Neonates received postnatal steroids.
  • Neonates whose mothers had a history of drug abuse during pregnancy.

研究组 & 干预措施

KMC 60 min group

Active Comparator

干预措施: KMC (Behavioral)

KMC 120 min group

Active Comparator

干预措施: KMC (Behavioral)

control group

Active Comparator

干预措施: KMC (Behavioral)

结局指标

主要结局

Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)

时间窗: the age of 36 weeks

applying Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) which is used to assess the neuro-behavioral performance of neonates.It consists of 13 subscales :Habituation, Attention, Arousal, Regulation, Handling procedures, Quality of movement, Excitability, Lethargy, Non-optimal reflexes, Asymmetric reflexes, Hypertonicity, and Stress/abstinence scale.Scores of subscales are from 1 to 9.

次要结局

  • Salivary cortisol(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dina Mohamed Mohamed Shinkar

Principal investigator

Ain Shams University

相似试验

Effect of KMC on Neurobehavior of Preterm Neonates | 临床试验