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

Enhancing the Survival of Low Birth Weight Infants in Low Resource Settings Using an Implementation Science Approach

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.

Study Overview

• Status: Completed
• Conditions: Preterm; Low Birthweight; Kangaroo Mother Care
• Intervention / Treatment: Behavioral: Peer Support and Baby Box

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.

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Sunyani, Ghana
    • Sunyani Regional Teaching Hospital
  • Greater Accra Region
    • Accra, Greater Accra Region, Ghana
      • Korle-Bu Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; Peer Support and Baby Box	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
No Intervention: Arm 2; Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Self-Efficacy as assessed by the Perceived Maternal Parenting Self-Efficacy Tool	The Perceived Maternal Parenting Self-Efficacy (PMP S-E) tool is a validated 18 item scale designed to assess maternal self-efficacy in caring for preterm infants, particularly in within a hospital setting. The scale evaluates a mother's confidence in her ability to care for her newborn across various domains such as recognizing and interpreting infant cues, providing physical care, and managing emotional responses. Each item is typically rated on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate a stronger sense of maternal competence and confidence in parenting skills.	7 and 28 days
Low birthweight stigma as assessed by the Small Baby Internalized Stigma Scale (SBISS)	The Small Baby Internalized Stigma Scale (SBISS) is an 8 item tool to assess both internalized and externalized stigma experienced by mothers of low birthweight infants. This scale captures experiences such as shame, blame, judgment from others, and self-stigmatization. Respondents rate items on a Likert scale, typically from 1 (Strongly Disagree) to 5 (Strongly Agree), resulting in a possible score range of 8 to 40. Higher scores indicate more intense experiences of stigma and potential emotional distress related to their infant's condition.	7 and 28 days
Maternal Stress as assessed by the Perceived Stress Scale	The Perceived Stress Scale (PSS) is a widely used, validated 10-item scale for measuring the perception of stress within the previous month. The PSS is applicable in various populations, including postpartum mothers, where it helps assess the emotional strain associated with caregiving and life transitions. Each item is rated on a 5-point scale from 0 (Never) to 4 (Very Often), yielding total scores ranging from 0 to 40. Higher scores indicate a higher perception of stress.	7 and 28 days
Social Support as assessed by the Perinatal Infant Care Social Support Scale	The Perinatal Infant Care Social Support Scale (PICSS) is a 24-item measure of perceived adequacy and availability of social support from family, friends and significant others during the perinatal period. This tool evaluates the emotional, informational, and instrumental support received from family, friends, and other social connections regarding infant care. Each item is scored on a scale of 0 (Not at all helpful) to 3 (Very helpful), resulting in a total score range of 0 to 96. Higher scores indicate stronger perceived support networks and resources available to the mother during a critical developmental and emotional time.	7 and 28 days
Maternal Depression as assessed by the Edinburg Postnatal Depression Scale	Edinburg Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire developed to screen for symptoms of postnatal depression, especially in low-resource settings. It focuses on the emotional and psychological well-being of mothers over the previous seven days, addressing symptoms such as sadness, guilt, anxiety, and thoughts of self-harm. Each item is scored from 0 to 3, leading to a total score between 0 and 30. Higher scores indicate more severe depressive symptoms levels.	7 and 28 days
Implementation barriers and facilitators as assessed by qualitative interviews	In-depth interviews (IDIs) will be conducted with mothers in the intervention group, peer supporters, study nurses, and healthcare workers to evaluate intervention implementation and contextualize barriers and facilitators for implementation from the perspectives of different stakeholders. Analysis will be guided by the Consolidated Framework for Implementation Research (CFIR).	baseline, 7 and 28 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): March 24, 2026
• Study Completion (Actual): March 24, 2026

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Preterm; Low-resource; Kangaroo Mother Care; Low birthweight
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: Pro00137641; 1R21HD116063-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Shared data will be de-identified, and the original data will be retained at the investigator's institution. Data and metadata from this project will be archived at the Inter-university Consortium for Political and Social Research (ICPSR).
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No