跳至主要内容
临床试验/CTRI/2024/06/069676
CTRI/2024/06/069676尚未招募不适用

Effect of kangaroo mother care on cerebral hemodynamics of very preterm neonates on non-invasive respiratory support- A prospective observational study

Fernandez Hospital1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2024年7月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
53
试验地点
1
主要终点
To estimate the changes in cerebral hemodynamics in very preterm neonates on non-invasive respiratory support during KMC using transcranial doppler ultrasonography in the first 3 days of its initiation.

研究概览

简要总结

In neonates who were born before term gestation especially before 34 weeks it is believed to cause an interruption in their smooth and integrated neurobehavioral development.

Preterm neonates are more susceptible to neuronal injury because of their physiological immaturities in cerebral vasculature and ineffective cerebral autoregulation which can cause marked fluctuations in cerebral blood flow. This results in adverse cerebrovascular events which can have longterm effects on neurodevelopment in the form of cognitive, motor and behavioral abnormalities.

The advances in perinatal and neonatal medicine over the past two decades improved the survival of extreme and very preterm neonates which also resulted in increased neuro-morbidity among the survivors. Hence neuroprotective strategies should be made an integral part of neonatal care thereby promoting better longterm neurodevelopmental outcomes.

Kangaroo Mother Care (KMC) is a proven and effective method of care for preterm infants which means skin-to-skin contact (SSC) between the neonate and the parent especially the mother. Preterm birth results in an increase in number of days of NICU stay and separation of newborn and the mother. This SSC between mother and the baby promotes a multi-sensory stimulation for their development.

As only few studies have shown the beneficial effects of KMC on cerebral hemodynamics in very preterm neonates who are given SSC as early as possible even on non-invasive respiratory support we wish to analyze the changes to make KMC an integral part of neuroprotective care among the neonates.

Most of the studies done on stable preterm neonates were around the gestational age of 30-34 weeks of gestation and less data on neonates between 26-30 weeks of gestation who require more days of respiratory support which might effect their neurodevelopmental outcomes and these are the newborns who are separated from their parents for a longer time and hence this study might help in giving earlier and aggressive KMC as part of developmentally supportive care in these newborns. The studies were done in a single session and the consistency of the results has not been studied well. In this study we wanted to study for at least a period of 3 days to know the efficacy in a broader way.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
0.00 Day(s) 至 99.00 Day(s)(—)
性别
All

入选标准

  • All Very preterm neonates born before 30 weeks of gestation, requiring non-invasive respiratory support and hemodynamically stable.

排除标准

  • Neonates born with major congenital anomaly, pre-existing neurological morbidities and hydrops.

结局指标

主要结局

To estimate the changes in cerebral hemodynamics in very preterm neonates on non-invasive respiratory support during KMC using transcranial doppler ultrasonography in the first 3 days of its initiation.

时间窗: From the starting of the initiation of KMC to the 2 consecutive days

次要结局

  • 1. To assess the changes in vital physiological parameters like heart rate, saturations and mean blood pressure before and after KMC during the first 3 days of initiation.(2) To analyze the regional cerebral oxygenation changes as measured by Near Infrared Spectroscopy (NIRS) during the first 3 days of its initiation.)

研究者

发起方
Fernandez Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Komaragiri Sai Sreevani

Fernandez Hospital, Hyderabad

研究点 (1)

Loading locations...

相似试验