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

NCT07364903 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1020

Last updated 2026-01-23

No results posted yet for this study

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

Interventions

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.

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

Sponsors & Collaborators

  • Mekelle University

    collaborator OTHER
  • Addis Ababa University

    collaborator OTHER
  • Laerdal Foundation

    lead OTHER

Principal Investigators

  • Siren Rettedal, MD, PhD · 1. Faculty of Health Sciences, University of Stavanger, Stavanger, Norway 2. Department of Simulation-based learning, Stavanger University Hospital, Norway

  • Hege Prof.Ersdal, MD, PhD · [email protected]

  • Damen Hailemariam, MD, PhD · [email protected]

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-16
Primary Completion
2026-06-15
Completion
2026-06-16

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07364903 on ClinicalTrials.gov