Low BirthweightNCT06937580
Enhancing the Survival of Low Birth Weight Infants in Low-Resource Settings
A study testing Peer Support and Baby Box in people with Low Birthweight and Preterm, run by University of South Carolina at 2 sites in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Low Birthweight, Preterm, Kangaroo Mother Care
- What is being tested?
- Peer Support and Baby Box
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 2 sitesGhana
- Study dates
- 1 Jul 2025to 24 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
2 sites in 1 country.
Ghana2 sites
Korle-Bu Teaching Hospital
Accra, Greater Accra Region
Sunyani Regional Teaching Hospital
Sunyani
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Birthweight, Preterm, Kangaroo Mother Care
- Being tested
- Peer Support and Baby Box
- Keywords
- Low birthweight, Preterm, Low-resource, Kangaroo Mother Care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Support and Baby BoxBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Peer Support and Baby Box Receives: Behavioral: Peer Support and Baby Box |
| Arm 2 | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 and 28 days
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: baseline, 7 and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Jul 2025
- Primary completion24 Mar 2026
- Study completion24 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low BirthweightStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Center for Learning and Childhood Development Ghana, Korle-Bu Teaching Hospital, Accra, Ghana, Sunyani Teaching Hospital, Sunyani, Ghana
- Responsible party
- Principal investigator, Mufaro Kanyangarara, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937580
- Sponsor's protocol ID
- Pro00137641
- Other IDs
- 1R21HD116063-01
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Survival of Low Birth Weight Infants in Low Resource Settings Using an Implementation Science Approach
- ClinicalTrials.gov ID
- NCT06937580
- Acronym / sponsor ID
- Pro00137641
- Conditions
- Low Birthweight, Preterm, Kangaroo Mother Care
- Keywords
- Low birthweight, Preterm, Low-resource, Kangaroo Mother Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Center for Learning and Childhood Development Ghana, Korle-Bu Teaching Hospital, Accra, Ghana, Sunyani Teaching Hospital, Sunyani, Ghana
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Behavioral: Peer Support and Baby BoxPeer Support and Baby Box |
| Arm 2 | No intervention | –Standard of care |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Support and Baby BoxThe 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 | Behavioural | Arm 1 |
Primary outcome
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.
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.
6 secondary outcomes
Maternal Self-Efficacy as assessed by the Perceived Maternal Parenting Self-Efficacy Tool
Time frame: 7 and 28 days
Low birthweight stigma as assessed by the Small Baby Internalized Stigma Scale (SBISS)
Time frame: 7 and 28 days
Maternal Stress as assessed by the Perceived Stress Scale
Time frame: 7 and 28 days
Social Support as assessed by the Perinatal Infant Care Social Support Scale
Time frame: 7 and 28 days
Maternal Depression as assessed by the Edinburg Postnatal Depression Scale
Time frame: 7 and 28 days
Implementation barriers and facilitators as assessed by qualitative interviews
Time frame: baseline, 7 and 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Support and Baby Box in people with Low Birthweight and Preterm, run by University of South Carolina at 2 sites in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of skin-to-skin contact based on self-report (time frame: 7 and 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.