Actively Recruiting

Phase Not Applicable
All Genders
NCT07364903

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

Led by Laerdal Foundation · Updated on 2026-01-23

1020

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

Sponsors

L

Laerdal Foundation

Lead Sponsor

M

Mekelle University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Neonates aged 0 to 28 days admitted to level-2 neonatal care units, including Kangaroo Mother care or mothers' side wards
  • Neonates requiring hospital stay of at least 48 hours
  • Accompanied by at least one parent or family member willing to spend up to 8 hours daily with the infant
Not Eligible

You will not qualify if you...

  • Neonates with major congenital anomalies
  • Infants without a family member to accompany them or whose family does not consent to spend up to 8 hours daily in the neonatal care unit
  • Families with confirmed physical or mental issues limiting their ability to communicate or engage
  • Families who leave against medical advice

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital

Mek'ele, Tigray, Ethiopia, 1871

Actively Recruiting

2

Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital

Mek'ele, Tigray, Ethiopia, 1871

Not Yet Recruiting

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Research Team

Z

Znabu Hadush Mr.Kahsay, MPH, PhD student

CONTACT

A

Araya Abrha Dr.Medhanyie, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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