Active — Not RecruitingNot Applicable

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

United States190 participantsStarted 2025-06-18

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 th…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Uptake of community-based Kangaroo Care use

Timeframe: 6 weeks

Trial details

NCT IDNCT07231432

SponsorUniversity of Massachusetts, Worcester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08-13

View on ClinicalTrials.gov More Preterm Birth trials