Clinical trial NCT06937580: Enhancing the Survival of Low Birth Weight Infants in Low-Resource Settings
Official title: Enhancing the Survival of Low Birth Weight Infants in Low Resource Settings Using an Implementation Science Approach
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Birthweight
Preterm
Kangaroo Mother Care
Keywords: Low birthweight
Preterm
Low-resource
Kangaroo Mother Care
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Center for Learning and Childhood Development Ghana
name: Korle-Bu Teaching Hospital, Accra, Ghana
name: Sunyani Teaching Hospital, Sunyani, Ghana
First posted: 2025-04-22
Enrollment: 328
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of skin-to-skin contact based on self-report
timeFrame: 7 and 28 days
measure: Exclusive breastfeeding based on self-report
timeFrame: 7 and 28 days
Secondary outcomes:
measure: Maternal Self-Efficacy as assessed by the Perceived Maternal Parenting Self-Efficacy Tool
timeFrame: 7 and 28 days
measure: Low birthweight stigma as assessed by the Small Baby Internalized Stigma Scale (SBISS)
timeFrame: 7 and 28 days
measure: Maternal Stress as assessed by the Perceived Stress Scale
timeFrame: 7 and 28 days
measure: Social Support as assessed by the Perinatal Infant Care Social Support Scale
timeFrame: 7 and 28 days
measure: Maternal Depression as assessed by the Edinburg Postnatal Depression Scale
timeFrame: 7 and 28 days
measure: Implementation barriers and facilitators as assessed by qualitative interviews
timeFrame: baseline, 7 and 28 days
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: Korle-Bu Teaching Hospital
state: Greater Accra Region
city: Sunyani
country: Ghana
facility: Sunyani Regional Teaching Hospital
Study officials:
References: