NCT07364903 Effectiveness of Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates
| NCT ID | NCT07364903 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laerdal Foundation |
| Condition | Family Involvement/Empowerment |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,020 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,020 participants in total. It began in 2025-12-16 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Siren Rettedal, MD, PhD
STUDY CHAIR
1. Faculty of Health Sciences, University of Stavanger, Stavanger, Norway 2. Department of Simulation-based learning, Stavanger University Hospital, Norway
Frequently Asked Questions
Who can join the NCT07364903 clinical trial?
This trial is open to participants of all sexes, studying Family Involvement/Empowerment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07364903 currently recruiting?
Yes, NCT07364903 is actively recruiting participants. Contact the research team at znabu.hadish@mu.edu.et for enrollment information.
Where is the NCT07364903 trial being conducted?
This trial is being conducted at Mek'ele, Ethiopia, Mek'ele, Ethiopia.
Who is sponsoring the NCT07364903 clinical trial?
NCT07364903 is sponsored by Laerdal Foundation. The principal investigator is Siren Rettedal, MD, PhD at 1. Faculty of Health Sciences, University of Stavanger, Stavanger, Norway 2. Department of Simulation-based learning, Stavanger University Hospital, Norway. The trial plans to enroll 1,020 participants.