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

NCT07364903 | Recruiting DMC

• 1 other identifier: LaerdalFoundation
• Study Type: interventional
• Target: 1,020
• Locations: 1 country
• Sites: 2

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.

Conditions

Family Involvement/Empowerment; Family-centered Care; Intensive Care Units, Neonatal; Family Integrated Newborn Care

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  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 Outcomes (7)

• Survival at discharge

  Starting from date of admission to the date of discharge within the first 28 days of the neonate's life

• Daily weight gain

  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

  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

  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

  Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life

Study Arms (2)

FINC arm

EXPERIMENTAL

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

Non-FINC arm

ACTIVE COMPARATOR

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

Interventions

Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates BEHAVIORAL

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.

Also known as: Family-Centered care, Family Involvement

FINC arm

Standard medical treatment BEHAVIORAL

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

Also known as: Conventional newborn care

Non-FINC arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Laerdal Foundation: lead
• Mekelle University: collaborator
• Addis Ababa University: collaborator

Study Sites (2)

Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital

Mek'ele, Tigray, 1871, Ethiopia

RECRUITING

Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital

Mek'ele, Tigray, 1871, Ethiopia

NOT YET RECRUITING

Related Publications (1)

• Kahsay ZH, Medhanyie AA, Mariam DH, Ersdal HL, Rettedal S. Feasibility of implementing family-integrated newborn care for hospitalised preterm and low birthweight infants in newborn care units of Ethiopia: a mixed-methods design. BMJ Open. 2025 Jan 21;15(1):e093377. doi: 10.1136/bmjopen-2024-093377.

  PMID: 39842933 BACKGROUND

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• 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 CHAIR

• Hege Prof.Ersdal, MD, PhD

  hege.ersdal@safer.net

  STUDY DIRECTOR

• Damen Hailemariam, MD, PhD

  damengoog@gmail.com

  STUDY DIRECTOR

Central Study Contacts

Znabu Hadush Mr.Kahsay, MPH, PhD student

CONTACT

+251 1920874140; znabu.hadish@mu.edu.et

Araya Abrha Dr.Medhanyie, PhD

CONTACT

+251933222222; araya.medhanyie@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 23, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 16, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: June 2027, one year after the completion of the trial
• 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

Locations

ET (2)