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NCT Number: NCT07231432

Promoting Kangaroo Care for Preterm or Low Birthweight 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Kangaroo Care Low Birth Weight Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Skin to Skin Contact Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Uptake of community-based Kangaroo Care use

    Time frame: 6 weeks

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

Secondary outcomes

  1. Maternal Intention to perform Kangaroo Care

    Time frame: Baseline (day 0)

    Self-report of intention to perform Kangaroo Care at home

  2. Maternal Self-Efficacy to perform Kangaroo Care

    Time frame: 6 weeks

    Maternal Self-Efficacy Scale questionnaire

  3. Adherence to community-based Kangaroo Care

    Time frame: 6 weeks

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

  4. Frequency of community-based Kangaroo Care use

    Time frame: 6 weeks

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

  5. Acceptability of the intervention

    Time frame: 6 weeks

    Client Satisfaction Questionnaire

  6. Appropriateness of the intervention

    Time frame: 6 weeks

    Qualitative Exit Interview with a trained member of the research staff

  7. Material Costs of the intervention

    Time frame: 6 weeks

    Cumulative cost of intervention delivery per participant

  8. Engagement with the intervention

    Time frame: 6 weeks

    Self-reported engagement with intervention (# of instances)

  9. Feasibility of the intervention

    Time frame: 6 weeks

    Feasibility of Intervention Measure questionnaire

  10. Usability of the intervention

    Time frame: 6 weeks

    System Usability Scale questionnaire

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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