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

NCT07231432 | Active Not Recruiting

• 2 other identifiers: K23HD112602K23HD112602-01A1
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Birth; Skin to Skin Contact; Low Birth Weight; Kangaroo Care

Outcome Measures

Primary Outcomes (1)

• Uptake of community-based Kangaroo Care use

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

  6 weeks

Secondary Outcomes (10)

• Maternal Intention to perform Kangaroo Care

  Baseline (day 0)

• Maternal Self-Efficacy to perform Kangaroo Care

  6 weeks

• Adherence to community-based Kangaroo Care

  6 weeks

• Frequency of community-based Kangaroo Care use

  6 weeks

• Acceptability of the intervention

  6 weeks

Study Arms (8)

Base Intervention + Behavioral Interventions A + B + C

EXPERIMENTAL

Behavioral: Behavioral Interventions

Base Intervention + Behavioral Interventions A + B

EXPERIMENTAL

Behavioral: Behavioral Interventions

Base Intervention + Behavioral Interventions A + C

EXPERIMENTAL

Behavioral: Behavioral Interventions

Base Intervention + Behavioral Intervention A

EXPERIMENTAL

Behavioral: Behavioral Interventions

Base Intervention + Behavioral Interventions B + C

EXPERIMENTAL

Behavioral: Behavioral Interventions

Base Intervention + Behavioral Intervention B

EXPERIMENTAL

Behavioral: Behavioral Interventions

Base Intervention + Behavioral Intervention C

EXPERIMENTAL

Behavioral: Behavioral Interventions

Base Intervention + No Experimental Behavioral Interventions

NO INTERVENTION

Interventions

Behavioral Interventions 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 + Behavioral Intervention A; Base Intervention + Behavioral Intervention B; Base Intervention + Behavioral Intervention C; Base Intervention + Behavioral Interventions A + B; Base Intervention + Behavioral Interventions A + B + C; Base Intervention + Behavioral Interventions A + C; Base Intervention + Behavioral Interventions B + C

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nisha Fahey, DO, MSc

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2025
• First Posted: November 17, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): August 13, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: All scientific data that can be shared from this project will be made available as soon as possible, and no later than 12 months of the end of the funding period. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.
• Access Criteria: All dataset(s) that can be shared, along with related metadata, will be deposited in the Harvard Dataverse Repository (https://dataverse.harvard.edu/). This will ensure the research community has long-term access to the data. Dataverse provides a DOI for the dataset related to this project, providing permanent identification for the data and ensuring that it will always be found with the same DOI. Its software platform provides a preservation and archival infrastructure and allows researchers to share, keep control of, and get recognition for their data through an easy-to-access web browser interface.

Locations

US (1)