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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-18

Study Completion Date

2028-12-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Preterm Birth Skin to Skin Contact Low Birth Weight Kangaroo Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Aim 1 consists of focus groups and qualitative analysis. Aim 2 consists of pilot testing interventions. Aim 3 includes the interventional study model, which is described here. As a part of the Multiphase Optimization Strategy (MOST) design-based trial, Aim 3 consists of an optimization trial using full factorial design to test combinations of intervention components, known as experimental conditions, and identify key combinations to include in an optimized, multicomponent intervention.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Intervention Type BEHAVIORAL

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.

Base Intervention + No Experimental Behavioral Interventions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Behavioral Interventions

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No