Promoting Kangaroo Care for Preterm or Low Birthweight Infants in Rural India

N/AActive Not RecruitingNCT07231432

University of Massachusetts, Worcester190 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

190

Conditions

Preterm Birth Skin to Skin Contact Low Birth Weight Kangaroo Care

Interventions

Behavioral InterventionsBEHAVIORAL

The interventions have not been determined yet. The intervention aspect of the study is not active at this time. This information will be updated at a later time to include more details.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

AIM 1 Mothers * 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 AIM 2 Mothers: * 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 AIM 3 Mothers: * 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 Exclusion Criteria (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

Locations (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Outcomes

Primary Outcomes

Uptake of community-based Kangaroo Care use

Self-report of any Kangaroo Care at home after NICU discharge

Time frame: 6 weeks

Secondary Outcomes

Maternal Intention to perform Kangaroo Care

Self-report of intention to perform Kangaroo Care at home

Time frame: Baseline (day 0)

Maternal Self-Efficacy to perform Kangaroo Care

Maternal Self-Efficacy Scale questionnaire

Time frame: 6 weeks

Adherence to community-based Kangaroo Care

Self-report of the last date Kangaroo Care was performed at home

Time frame: 6 weeks

Frequency of community-based Kangaroo Care use

Self-report of number of days Kangaroo Care was provided at home

Time frame: 6 weeks

Acceptability of the intervention

Client Satisfaction Questionnaire

Time frame: 6 weeks

Appropriateness of the intervention

Qualitative Exit Interview with a trained member of the research staff

Time frame: 6 weeks

Material Costs of the intervention

Cumulative cost of intervention delivery per participant

Time frame: 6 weeks

Engagement with the intervention

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.