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

NCT06937580 | Completed DMC

• 2 other identifiers: Pro001376411R21HD116063-01
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Low birthweight; Preterm; Low-resource; Kangaroo Mother Care

Outcome Measures

Primary Outcomes (2)

• Duration of skin-to-skin contact based on self-report

  Duration of skin-to-skin contact in hours and minutes will be assessed at 7 and 28 days using an interviewer-administered questionnaire to mothers.

  7 and 28 days

• Exclusive breastfeeding based on self-report

  Current feeding practices will be assessed at 7 and 28 days using an interviewer-administered questionnaire to mothers.

  7 and 28 days

Secondary Outcomes (6)

• Maternal Self-Efficacy as assessed by the Perceived Maternal Parenting Self-Efficacy Tool

  7 and 28 days

• Low birthweight stigma as assessed by the Small Baby Internalized Stigma Scale (SBISS)

  7 and 28 days

• Maternal Stress as assessed by the Perceived Stress Scale

  7 and 28 days

• Social Support as assessed by the Perinatal Infant Care Social Support Scale

  7 and 28 days

• Maternal Depression as assessed by the Edinburg Postnatal Depression Scale

  7 and 28 days

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Peer Support and Baby Box

Behavioral: Peer Support and Baby Box

Arm 2

NO INTERVENTION

Standard of care

Interventions

Peer Support and Baby Box BEHAVIORAL

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

Arm 1

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: Mother-infant
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

The study will consider mother-infant dyads eligible for participation if they meet all of the following criteria: * Mothers aged between 15 and 49 years. * Mothers intending to initiate facility-based Kangaroo Care, irrespective of gestational age, delivery mode, or singleton or multiple birth status. * Mothers capable of providing consent or those unwilling to provide consent. * Mothers without medical complications hindering Kangaroo Care. * Mothers residing within a 10-kilometer radius of the study site. * Infants capable of spontaneous breathing within 1 hour of birth. * Infants without major congenital malformations.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of South Carolina: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Center for Learning and Childhood Development Ghana: collaborator
• Korle-Bu Teaching Hospital, Accra, Ghana: collaborator
• Sunyani Teaching Hospital, Sunyani, Ghana: collaborator

Study Sites (2)

Korle-Bu Teaching Hospital

Accra, Greater Accra Region, Ghana

Location

Sunyani Regional Teaching Hospital

Sunyani, Ghana

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study consists of a two-arm, unblinded individual randomized controlled trial to determine the effectiveness of receiving peer support and a Baby Box. The mothers in the intervention arm will receive the peer support and Baby Box, while the control arm will consist of mothers receiving standard care.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 22, 2025
• Study Start: July 1, 2025
• Primary Completion: March 24, 2026
• Study Completion: March 24, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The investigators will liaise with ICPSR to allow for about 3 months before the required release date to account for any potential lag time between submission and data release. The permanently archived data will be available to domain specialists, ensuring data longevity across changing technologies, new media, and data formats.
• Access Criteria: The investigators will provide analytic code for linking, merging, or manipulating datasets, which ICPSR will make available alongside the data. ICPSR will produce standardized project-level and variable-level metadata that conform to the Data Documentation Initiative (DDI) metadata standard, ensuring compatibility with other data archive catalogs. The archived data will be available for long-term access by domain specialists. Public data users will access the de-identified data through ICPSR after registration and compliance with ICPSR's Terms of Use. Data users will be bound by the Restricted Data Use Agreement, ensuring the confidentiality of human subjects.

Locations

GH (2)