Promoting Community-based Kangaroo Care Among Mothers of Low Birth Weight Infants in Rural India
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Uptake of community-based Kangaroo Care use
研究概览
简要总结
The goal of this study is to develop ways to help mothers of preterm or low birth weight infants do Kangaroo Care at home after discharge from the Neonatal Intensive Care Unit in rural India.
详细描述
This study aims to create and evaluate interventions to support the practice of Kangaroo Care among mothers of preterm or low birth weight infants in the community-seeing after discharge from the Neonatal Intensive Care Unity. Using a mixed methods and Multiphase Optimization Strategy (MOST) design-based trial, we aim to: Aim 1: Use community-engaged research and qualitative methods to refine up to four individual candidate interventions to overcome barriers to community-based Kangaroo Care, Aim 2: Pilot individual candidate interventions to assess implementation outcomes and define optimization criterion tailored for the community setting, Aim 3: Conduct a MOST design-based optimization trial to develop a community-informed, multicomponent intervention to promote community-based Kangaroo Care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mothers of former low birthweight (<2500 grams at birth) infants who were hospitalized in the Shree Krishna Hospital NICU
- •Performed Kangaroo Care during their infant's hospitalization
- •Live in a village that is "adopted" by and within a 50-kilometer radius of Shree Krishna Hospital
- •At least 18 years old
- •Speak Gujarati
- •Healthcare Providers- Physicians:
- •Physicians and nurses who work in either the Shree Krishna Hospital NICU or in community settings within a 50-kilometer radius who provide newborn care to at least 3 newborns each week
- •At least 18 years old
- •Speak Gujarati
- •Village Health Workers:
- •Village health workers who operate in one of the "adopted" villages within a 50-kilometer radius of Shree Krishna Hospital
- •We will aim to recruit one health worker from 10 of the 15 subregions of the district of Anand, based on geography
- •At least 18 years old
- •Speak Gujarati
- •Mothers of an infant born with low birthweight (< 2500g) who is hospitalized in the NICU at Shree Krishna Hospital with an anticipated discharge weight of less than 2500g
- •Must reside in a village "adopted" by and 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
- •Mothers of an infant born with low birthweight (< 2500g) who is hospitalized in the NICU at Shree Krishna Hospital with an anticipated discharge weight of less than 2500g
- •Must reside in a village "adopted" by and 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
- •(applicable to all aims)
- •Persons unable to provide informed consent
- •Pregnant women may enroll in this study, though, we will not be intentionally recruiting pregnant women. (Refer to section 18 for more information on this)
- •Prisoners will not be included in the study
研究组 & 干预措施
Base Intervention + Behavioral Interventions B + C
干预措施: Behavioral Interventions (Behavioral)
Base Intervention + Behavioral Intervention B
干预措施: Behavioral Interventions (Behavioral)
Base Intervention + Behavioral Intervention A
干预措施: Behavioral Interventions (Behavioral)
Base Intervention + Behavioral Intervention C
干预措施: Behavioral Interventions (Behavioral)
Base Intervention + No Experimental Behavioral Interventions
Base Intervention + Behavioral Interventions A + B + C
干预措施: Behavioral Interventions (Behavioral)
Base Intervention + Behavioral Interventions A + B
干预措施: Behavioral Interventions (Behavioral)
Base Intervention + Behavioral Interventions A + C
干预措施: Behavioral Interventions (Behavioral)
结局指标
主要结局
Uptake of community-based Kangaroo Care use
时间窗: 6 weeks
Self-report of any Kangaroo Care at home after NICU discharge
次要结局
- Usability of the intervention(6 weeks)
- Acceptability of the intervention(6 weeks)
- Engagement with the intervention(6 weeks)
- Adherence to community-based Kangaroo Care(6 weeks)
- Frequency of community-based Kangaroo Care use(6 weeks)
- Maternal Intention to perform Kangaroo Care(Baseline (day 0))
- Maternal Self-Efficacy to perform Kangaroo Care(6 weeks)
- Appropriateness of the intervention(6 weeks)
- Material Costs of the intervention(6 weeks)
- Feasibility of the intervention(6 weeks)
研究者
Nisha Fahey
Assistant Professor of Pediatrics
University of Massachusetts, Worcester