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

November 13, 2025 updated by: Nisha Fahey, University of Massachusetts, Worcester

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Uptake of community-based Kangaroo Care use
Time Frame: 6 weeks
Self-report of any Kangaroo Care at home after NICU discharge
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal Intention to perform Kangaroo Care
Time Frame: Baseline (day 0)
Self-report of intention to perform Kangaroo Care at home
Baseline (day 0)
Maternal Self-Efficacy to perform Kangaroo Care
Time Frame: 6 weeks
Maternal Self-Efficacy Scale questionnaire
6 weeks
Adherence to community-based Kangaroo Care
Time Frame: 6 weeks
Self-report of the last date Kangaroo Care was performed at home
6 weeks
Frequency of community-based Kangaroo Care use
Time Frame: 6 weeks
Self-report of number of days Kangaroo Care was provided at home
6 weeks
Acceptability of the intervention
Time Frame: 6 weeks
Client Satisfaction Questionnaire
6 weeks
Appropriateness of the intervention
Time Frame: 6 weeks
Qualitative Exit Interview with a trained member of the research staff
6 weeks
Material Costs of the intervention
Time Frame: 6 weeks
Cumulative cost of intervention delivery per participant
6 weeks
Engagement with the intervention
Time Frame: 6 weeks
Self-reported engagement with intervention (# of instances)
6 weeks
Feasibility of the intervention
Time Frame: 6 weeks
Feasibility of Intervention Measure questionnaire
6 weeks
Usability of the intervention
Time Frame: 6 weeks
System Usability Scale questionnaire
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Worcester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nisha Fahey, DO, MSc, University of Massachusetts Chan Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 13, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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