Family-integrated newborn care for preterm and low-birth-weight babies
Effectiveness of Implementing Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates in Resource-limited Settings; Quasi-experimental Design
This project will try training and integrating parents into hospital care for preterm and low-birth-weight newborns in Tigray to see if it shortens hospital stays and improves outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1020 (estimated) |
| Sex | All |
| Sponsor | Laerdal Foundation Academic / other |
| Locations | 2 sites (Mek'ele, Tigray and 1 other locations) |
| Trial ID | NCT07364903 on ClinicalTrials.gov |
What this trial studies
This quasi-experimental project enrolls about 1,020 parent–neonate pairs across three level-2 neonatal units in Mek'ele, Wukro, and Adigrat and uses non-equivalent comparison groups. Families in the intervention hospitals receive training, mentoring, and integration into routine newborn care while staff also receive education and infection-prevention support, and control hospitals continue standard medical treatment. The main outcome is length of hospital stay for preterm and low-birth-weight neonates, with effect sizes estimated using general linear models and comparisons to conventional care. The project will also measure uptake and acceptability of the intervention and other neonatal and parental outcomes.
Who should consider this trial
Good fit: Ideal candidates are preterm or low-birth-weight neonates aged 0–28 days admitted to level-2 NCUs at the participating hospitals who have at least one parent able and willing to spend up to eight hours per day with the infant.
Not a fit: Babies with major congenital anomalies, those without a family member able or willing to stay for the required hours, or families with severe physical or mental limitations are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could shorten hospital stays, improve survival and growth, and give families practical skills to care for preterm and low-birth-weight infants in low-resource settings.
How similar studies have performed: Family-integrated care and kangaroo mother care have shown benefits for neonatal outcomes in several studies, mainly in higher-resource settings, but evidence from low-resource regions like Tigray is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All neonates aged 0-28 days admitted to level-2 NCUs in the neonatal care unit, including Kangaroo Mother care ward or mothers' side ward, with conditions that require hospital stay at 48 hours; and * accompanied by at least one parent (preferably a mother) dedicated to spending up to 8 hours per day with the infant Exclusion Criteria: * Neonates with major congenital anomalies * Infants with no family member to accompany the infant, or who do not consent to spend up to 8 hours per day in the NCU * Families with confirmed physical and/or mental problems limiting their capability to communicate and to engage, or those who leave against medical advice
Where this trial is running
Mek'ele, Tigray and 1 other locations
- Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital — Mek'ele, Tigray, Ethiopia (Recruiting)
- Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital — Mek'ele, Tigray, Ethiopia (Not_yet_recruiting)
Study contacts
- Study coordinator: Znabu Hadush Mr.Kahsay, MPH, PhD student
- Email: znabu.hadish@mu.edu.et
- Phone: +251 1920874140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.