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

April 29, 2026 updated by: Mufaro Kanyangarara, University of South Carolina

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
328

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duration of skin-to-skin contact based on self-report
Time Frame: 7 and 28 days
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
Time Frame: 7 and 28 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal Self-Efficacy as assessed by the Perceived Maternal Parenting Self-Efficacy Tool
Time Frame: 7 and 28 days
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)
Time Frame: 7 and 28 days
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
Time Frame: 7 and 28 days
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
Time Frame: 7 and 28 days
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
Time Frame: 7 and 28 days
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
Time Frame: baseline, 7 and 28 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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