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ACTIVE NOT RECRUITING

NCT07231432

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

Sponsor: University of Massachusetts, Worcester

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2025-06-18

Completion Date

2028-12-01

Last Updated

2025-11-17

Healthy Volunteers

Conditions

Preterm Birth Skin to Skin Contact Low Birth Weight Kangaroo Care

Interventions

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.

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

Locations (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States