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

NCT06937580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Low Birthweight
  • Preterm
  • Kangaroo Mother Care

Interventions

BEHAVIORAL

Peer Support and Baby Box

The intervention consists of five one-on-one peer support sessions and a Baby Box consisting of a woolen hat and socks for infant warmth, a cloth wrap to position the baby securely for skin-to-skin contact and improve comfort, a bar of soap for hygiene, and a real-time continuous temperature monitoring device for hypothermia detection

Sponsors & Collaborators

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

    collaborator NIH
  • Center for Learning and Childhood Development Ghana

    collaborator UNKNOWN
  • Korle-Bu Teaching Hospital, Accra, Ghana

    collaborator OTHER
  • Sunyani Teaching Hospital, Sunyani, Ghana

    collaborator UNKNOWN
  • University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-03-24
Completion
2026-03-24

Countries

  • Ghana

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06937580 on ClinicalTrials.gov