NCT07364903

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,020 (estimated)
• Sponsor: Laerdal Foundation · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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?

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-16
• Primary completion: 2026-06-15
• Completion: 2026-06-16
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

2 sites across 1 country: Ethiopia