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临床试验/CTRI/2025/04/083903
CTRI/2025/04/083903尚未招募不适用

Kangaroo Care in India

National Institutes of Health (NIH)1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年5月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
160
试验地点
1
主要终点
Uptake, Frequency, and Adherence of community-based Kangaroo Care

研究概览

简要总结

This research seeks to develop a community-informed, multicomponent intervention to

promote the practice of community-based Kangaroo Care after NICU discharge among

mothers of infants born with low birth weight.

 One in five neonatal deaths worldwide occur in India and India has the highest incidence of

preterm birth worldwide. Kangaroo Care is a low-cost, efficacious intervention, featuring skin-to-skin care, that improves outcomes among low-birth-weight infants. The World Health Organization recommends Kangaroo Care until infants reach 2500 grams or 40 weeks corrected gestational age, which can take weeks to months. A critical gap in the current efforts to promote Kangaroo Care surrounds the transition period from facility to the community.

ï‚· Aim 1: Use focus groups to refine individual candidate interventions to overcome barriers to community-based Kangaroo Care

ï‚· Aim 2: Pilot test candidate interventions and define optimization criterion to be used

in the optimization phase of a multiphase optimization strategy (MOST) design-based trial

ï‚· Aim 3: Conduct a MOST design-based optimization trial to build an integrated,

multicomponent intervention to promote community-based Kangaroo Care

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
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Mothers of an infant born with low birthweight who is hospitalized in the NICU at Shree Krishna Hospital with an anticipated discharge weight of less than 2500g
  • Must reside in a village within a 50 kilometer radius of Shree Krishna Hospital and plan to live there for at least 6 weeks after NICU discharge
  • Speaks Gujarati
  • At least 18 years old.

排除标准

  • 未提供

结局指标

主要结局

Uptake, Frequency, and Adherence of community-based Kangaroo Care

时间窗: At discharge, one months after discharge and three months after discharge

次要结局

  • Maternal Intention and Self-Efficacy for Kangaroo Care(These behavioral belief outcomes will be assessed through standardized questionnaires. At baseline, participants will complete a questionnaire about their intention to perform community-based Kangaroo Care at home. After 6 weeks, they will complete the Maternal Self-Efficacy Scale.)
  • Implementation Outcomes(Implementation outcomes (acceptability, appropriateness, material costs, engagement, feasibility, and usability) will be assessed using qualitative and quantitative measurements throughout the 6-week follow up period.)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

SOMASHEKHAR NIMBALKAR

BHAIKAKA UNIVERSITY

研究点 (1)

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