NCT06937580

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

Recruiting now NA Last updated 29 July 2025

What this trial tests

NA trial testing Peer Support and Baby Box in Low Birthweight in 328 participants. Currently enrolling.

Timeline

1 July 2025

Primary endpoint
30 August 2026

31 December 2026

Quick facts

Lead sponsor	University of South Carolina
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	328
Start date	1 July 2025
Primary completion	30 August 2026
Estimated completion	31 December 2026
Sites	2 locations across Ghana

Drugs / interventions tested

• Peer Support and Baby Box

Conditions studied

• Low Birthweight — all drugs for Low Birthweight →
• Preterm — all drugs for Preterm →
• Kangaroo Mother Care — all drugs for Kangaroo Mother Care →

Sponsor

University of South Carolina

Who can join

Adults 15 to 49, female only, with Low Birthweight or Preterm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.