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Effectiveness of Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates

RecruitingNAAges any - anyAllLaerdal Foundation
NCT07364903 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates
  • Standard medical treatment
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Where

2 sites
Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital
Mek'ele, Ethiopia
Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital
Mek'ele, Ethiopia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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