Clinical Trial

Enhancing the Survival of Low Birth Weight Infants in Low-Resource Settings

Completed
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Summary
Kangaroo Care, which includes skin-to-skin contact, exclusive breastfeeding, and timely follow-up, is a proven method to reduce neonatal morbidity and mortality in low-resource settings where the risks of prematurity, neonatal hypothermia, and neonatal mortality are high. However, numerous challenges such as inadequate knowledge, financial constraints, cultural norms, stigma, and limited social support impede its effective practice among mothers of low birthweight infants. To address these barriers, the intervention consists of informational, emotional and motivational support from trained peers and a box with warmth-related items to support the adoption and sustainment of Kangaroo Care at home. The investigators will enroll 328 mothers of low birthweight infants, who intend to initiate Kangaroo Care at two tertiary hospitals in Ghana, in a prospective randomized controlled trial. The trial aims to evaluate the effectiveness of the intervention in increasing exclusive breastfeeding rates and the duration of skin-to-skin contact at 7 and 28 days post-hospital discharge. Mothers in the control group will receive the standard of care, which consists of one counseling session on Kangaroo Care before discharge and a follow-up phone call after discharge. In addition to the standard of care, mothers in the intervention group will receive five one-on-one peer support sessions over one month, along with a box containing a hat, socks, a specialized wrap to support skin-to-skin contact, soap for hand hygiene, and a temperature monitoring device that alerts mothers if their infant becomes hypothermic. Using surveys, outcome data will be collected from both study groups at enrollment in the hospital, and at 7 and 28 days after discharge at participants' homes. Additionally, in-depth interviews will be conducted with 10-15 mothers from the intervention group, 10-15 healthcare workers, and all six peer supporters delivering the intervention. These interviews will explore the implementation of the intervention and contextualize barriers and facilitators from the perspectives of different stakeholders.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-17; most recent amendment 2026-04-29.
Status change: Recruiting → Completed 2026-04-29
Status change: Not Yet Recruiting → Recruiting 2025-07-24
Trial Details
NCT Number NCT06937580
Lead Sponsor University of South Carolina
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Center for Learning and Childhood Development Ghana, Korle-Bu Teaching Hospital, Accra, Ghana, Sunyani Teaching Hospital, Sunyani, Ghana
Conditions Low Birthweight, Preterm, Kangaroo Mother Care
Enrollment 328 participants
Start Date 2025-07-01
Primary Completion 2026-03-24 (estimated)
Study Completion 2026-03-24 (estimated)
Updated on ClinicalTrials.gov 2026-05-05