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临床试验/CTRI/2025/02/080726
CTRI/2025/02/080726尚未招募不适用

Comparision of effect of cerebral blood flow in preterm neonates during kmc given by father vs mother - a cross over randomized study

Bhaikaka University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月3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
50
试验地点
1
主要终点
Reduction rate of Resistive Index in MCA

研究概览

简要总结

Skin-to-skin care, also known as Kangaroo Mother Care (KMC), is a highly regarded and extensively studied intervention for preterm neonates, involving the prone, upright positioning of the neonate in direct skin-to-skin contact on the maternal chest. KMC is associated with numerous health benefits for both the mother and the infant, including reductions in morbidity and mortality, enhanced breastfeeding success, increased weight gain, and improved mother-infant bonding [1,2]. Additionally, KMC has been shown to influence the development of neural connections, contributing to long-term cognitive benefits such as brain maturation, increased brain complexity, and better sleep organization. While the majority of research on KMC has concentrated on its effects on cardio respiratory parameters, the impact on cerebral hemodynamics remains less explored. Cerebral blood flow (CBF) is a critical component of cerebral hemodynamics and has been previously investigated in asphyxiated and preterm infants. However, no study has yet been performed on the response of cerebral blood flow (CBF) in preterm infants during KMC given by father and mother separately [3-6].

The assessment of CBF and cerebral hemodynamics can be effectively conducted using pulsed Doppler ultrasound techniques [7-9]. Spectral Doppler analysis and color flow mapping are widely utilized in the evaluation of cerebral hemodynamic changes in premature neonates, offering enhanced visualization of cerebral vessels and accurate quantification of blood flow variations over time [8].

This study aims to elucidate the differential effects of KMC provided by mothers and fathers on cerebral hemodynamic indices, specifically targeting the middle cerebral artery, alongside vital parameters in stable preterm infants.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Day(s) 至 1.00 Month(s)(—)
性别
All

入选标准

  • All Newborns eligible for KMC.

排除标准

  • 未提供

结局指标

主要结局

Reduction rate of Resistive Index in MCA

时间窗: One hour of KMC. Day 1 of intervention.

次要结局

  • Pulsatility Index(Peak Systolic Velocity)

研究者

发起方
Bhaikaka University
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr. Somashekhar Nimbalkar

Bhaikaka University

研究点 (1)

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