Effectiveness of Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates
Recruiting now · Not applicable
Conditions studied: Family Involvement/Empowerment, Family-centered Care, Intensive Care Units, Neonatal, Family Integrated Newborn Care
In brief
The goal of this quasi-experimental study is to learn if integrating family in newborn care units as a key partner can improve the outcomes of preterm and low-birth-weight neonates. The main question\[s\] that the study aims to answer: • Does the implementation of the FINC intervention impact the neonatal outcomes for preterm and low-birth weight neonates in NCUs in resource-limited settings of Tigray, Northern Ethiopia? Researchers will compare the Length of hospital stay among preterm and low-birth-weight neonates admitted to hospitals included in the intervention groups and compared to the neonates admitted to hospitals in the control group. In the intervention groups, family of preterm and low-birth-weight neonates will be trained, mentored, and integrated into the care targeted to their neonates.
Key facts
- Study ID
- NCT07364903
- Run by
- Laerdal Foundation
- People needed
- 1020
- Starts
- 2025-12-16
- Expected to finish
- 2026-06-16
- Last updated by the study team
- 2026-01-23
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital — Mek'ele, Tigray, Ethiopia (enrolling)
- Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital — Mek'ele, Tigray, Ethiopia
Full record on ClinicalTrials.gov
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