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

January 18, 2026 updated by: Znabu Hadush Kahsay, Laerdal Foundation

Effectiveness of Implementing Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates in Resource-limited Settings; Quasi-experimental Design

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The World Health Organization recommends Family involvement and support in the management of preterm and low birth weight neonates. However, the body of literature on its effectiveness in low-resource settings is scanty. The current study aimed to investigate the effectiveness of implementing Family-Integrated Newborn Care to improve outcomes for preterm and low-birth weight Neonates in resource-limited settings in resource-limited settings of Ethiopia. A quasi-experimental design with non-equivalent comparison groups will be employed among 1020 family-neonate dyads in three hospitals with level-2 Neonatal Care Units. The intervention package will mainly consist of training and education sessions for health care providers and families supplemented by measures to ensure infection prevention in level-2 neonatal care units. The effect size of implementing Family-Integrated Newborn Care on neonatal and parental outcomes will be estimated using General Linear Models (GLM) and compared with the conventional care. Research questions are:

  1. 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?
  2. Was the uptake of implementation of the FINC intervention for preterm and low-birth-weight neonates acceptable?

Study Type

Interventional

Enrollment (Estimated)

1020

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ethiopia
    • Tigray
      • Mek'ele, Tigray, Ethiopia, 1871
        • Recruiting
        • Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Znabu Hadush Kahsay, MPH, PhD studnet
        • Sub-Investigator:
          • Araya Abrha Medhanyie, PhD
      • Mek'ele, Tigray, Ethiopia, 1871
        • Not yet recruiting
        • Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FINC arm
This arm includes the family of the neonates assigned to the experimental group, and they will receive a FINC intervention. The FINC intervention, families of preterm and low-birth weight neonates aged 0-28 days will be trained, educated, and encouraged to get involved in the newborn care targeted to their neonates.
Behavioral: Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates
The Family Integrated Newborn Care intervention includes undergoing 1) minor modifications in the NCU space and physical infrastructure conducive to family integration; 2) bedside training for families, and 3) provision of ten audio-visual materials in the local language (Tigrigna) demonstrating family integration in key caring activities targeted to their neonates.
Other Names:
  • Family-Centered care
  • Family Involvement
Active Comparator: Non-FINC arm
This arm includes the families of the neonates assigned to the comparator group, who will receive conventional or standard care. No special effort that the routine care will be provided to integrate the family into the care targeted to the preterm and low-birth-weight neonates
Behavioral: Standard medical treatment
The preterm and low-birth weight neonates will receive the conventional care with no special attention to integrate the families in the care targeted to the neonates
Other Names:
  • Conventional newborn care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: The period from the date of admission to the date of discharge is within the first 28 days of neonat's life.
It refers to the duration a neonate stays in the hospital for care, starting from admission to discharge home
The period from the date of admission to the date of discharge is within the first 28 days of neonat's life.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival at discharge
Time Frame: Starting from date of admission to the date of discharge within the first 28 days of the neonate's life
Survival status of the neonate at discharge, specified as alive, dead, or referred for higher-level care, or left against medical advice.
Starting from date of admission to the date of discharge within the first 28 days of the neonate's life
Daily weight gain
Time Frame: Starting from the date of admission up to the date of discharge and assessed in the first 28 days of the neonate's life
The net weight gain of a neonate each day (in grams/kg/day) in reference to the expected gain for the body mass
Starting from the date of admission up to the date of discharge and assessed in the first 28 days of the neonate's life
Time to initiate breastfeeding after admission
Time Frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
The time the breastfeeding of the neonate is initiated for the first time since admission
Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
Time to initiate skin-to-skin after admission
Time Frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
The first time skin-to-skin is initiated for the neonate, since the date of admission to the Neonatal Intensive Care Unit (NICU)
Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
The number of days on Antibiotics
Time Frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
The total number of days the neonate received antibiotics for being suspected or diagnosed with sepsis
Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
Score for parental stress monitoring scale
Time Frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
A score for the parental stress monitoring scale, which consists of eight items in a five-point Likert scale, with scores ranging from a lower score (1= Not stressful at all) to a higher score (5= Extremely stressful).
Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
Discharge readiness score on the day of the discharge
Time Frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
The score for the discharge readiness scale, consisting of eight items in a five-point Likert scale, to assess parents' readiness at the time of discharge. The score level ranges from a lower score (1= Extremely low confidence) to a higher score (5= Extremely high confidence).
Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laerdal Foundation

Collaborators

Addis Ababa University
Mekelle University

Investigators

  • Study Chair: Siren Rettedal, MD, PhD, 1. Faculty of Health Sciences, University of Stavanger, Stavanger, Norway 2. Department of Simulation-based learning, Stavanger University Hospital, Norway
  • Study Director: Hege Prof.Ersdal, MD, PhD, hege.ersdal@safer.net
  • Study Director: Damen Hailemariam, MD, PhD, damengoog@gmail.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2025

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 16, 2026

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LaerdalFoundation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study is part of a PhD study. The dataset consists of inpatient data will be shared after the manuscript summarizing the key findings of the trial is published. Hence, the dataset will be made available open for the public in June 2027. In addition, the IPD can be shared up on reasonable request form the contact person of the study.

IPD Sharing Time Frame

June 2027, one year after the completion of the trial

IPD Sharing Access Criteria

The IPD will be available in the data repository for Mekelle University based on the notification to the contact person of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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