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

Promoting Community-based Kangaroo Care Among Mothers of Low Birth Weight Infants in Rural India

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Preterm Birth; Low Birth Weight; Skin to Skin Contact; Kangaroo Care
• Intervention / Treatment: Behavioral: Behavioral Interventions

Detailed Description

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
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Chan Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Base Intervention + Behavioral Interventions A + B + C	Behavioral: 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.
Experimental: Base Intervention + Behavioral Interventions A + B	Behavioral: 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.
Experimental: Base Intervention + Behavioral Interventions A + C	Behavioral: 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.
Experimental: Base Intervention + Behavioral Intervention A	Behavioral: 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.
Experimental: Base Intervention + Behavioral Interventions B + C	Behavioral: 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.
Experimental: Base Intervention + Behavioral Intervention B	Behavioral: 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.
Experimental: Base Intervention + Behavioral Intervention C	Behavioral: 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.
No Intervention: Base Intervention + No Experimental Behavioral Interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of community-based Kangaroo Care use	Self-report of any Kangaroo Care at home after NICU discharge	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Intention to perform Kangaroo Care	Self-report of intention to perform Kangaroo Care at home	Baseline (day 0)
Maternal Self-Efficacy to perform Kangaroo Care	Maternal Self-Efficacy Scale questionnaire	6 weeks
Adherence to community-based Kangaroo Care	Self-report of the last date Kangaroo Care was performed at home	6 weeks
Frequency of community-based Kangaroo Care use	Self-report of number of days Kangaroo Care was provided at home	6 weeks
Acceptability of the intervention	Client Satisfaction Questionnaire	6 weeks
Appropriateness of the intervention	Qualitative Exit Interview with a trained member of the research staff	6 weeks
Material Costs of the intervention	Cumulative cost of intervention delivery per participant	6 weeks
Engagement with the intervention	Self-reported engagement with intervention (# of instances)	6 weeks
Feasibility of the intervention	Feasibility of Intervention Measure questionnaire	6 weeks
Usability of the intervention	System Usability Scale questionnaire	6 weeks

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Nisha Fahey, DO, MSc, University of Massachusetts Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2025
• Primary Completion (Estimated): August 13, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 12, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy
• Other Study ID Numbers: K23HD112602 (U.S. NIH Grant/Contract); K23HD112602-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sufficient data from this project will be preserved to validate and replicate research findings described in the Aims. The final dataset will include self-reported demographics, behavioral beliefs, acceptability, appropriateness, material costs, engagement, feasibility, usability, uptake, frequency, and adherence. Additional data sets will include coded qualitative data. We will share de-identified individual participant-level data.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No