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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Globally, about 20 million infants are born with low birthweight (LBW), and these infants face a myriad of health challenges, including difficulties in regulating body temperature, poor nutritional status, increased vulnerability to infections, and delayed development, placing emotional and financial burdens on families. Kangaroo Care (KC), consisting of continuous skin-to-skin contact, exclusive breastfeeding, and early discharge, is an evidence-based intervention recommended for LBW newborns to improve their survival and healthy development, especially in low-resource settings where the risks of prematurity, neonatal hypothermia, and neonatal mortality are disproportionately high. Despite the effectiveness of KC, widespread scale-up has been slow due to barriers to implementation and adoption. Existing efforts have primarily focused on health systems and policy changes, neglecting the need to support mothers and families to continue practicing KC at home. Several sociocultural and economic factors, including lack of essential warmth-related items, cultural norms, stigma, and limited social support, hinder the KC continuation at home. To address these challenges, an intervention grounded in the Information, Motivation, and Behavior (IMB) model has been developed. The intervention offers emotional, informational, and motivational peer support to mothers of LBW infants and a kit containing low-cost, locally sourced neonatal care items to facilitate skin-to-skin contact and breastfeeding. A type II hybrid effectiveness-implementation study will be conducted. First, the effectiveness of the intervention will be tested using an individual randomized controlled trial, enrolling 328 mother-infant dyads eligible for KC from two tertiary hospitals in Ghana (Aim 1). It is hypothesized that mothers receiving the intervention will be more likely to continue KC at home 7 days after discharge compared to those in the control group receiving the standard of care. The primary effectiveness outcome is any duration of skin-to-skin contact and exclusive breastfeeding at 7 and 28 days post-discharge. Second, the implementation process including associated barriers and facilitators to implementation will be explored using mixed methods (Aim 2). In-depth interviews will be conducted with participants, peer supporters and healthcare workers. Thematic analysis of the interviews will be guided by the Consolidated Framework for Implementation Research (CFIR) framework and combine both inductive and deductive approaches. Findings from this research will inform the development of effective models for KC implementation and scale-up.

Conditions

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Low Birthweight Preterm Kangaroo Mother Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm 1

Peer Support and Baby Box

Group Type ACTIVE_COMPARATOR

Peer Support and Baby Box

Intervention Type 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 2

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No