RecruitingNot ApplicableNCT07364903

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


Sponsor

Laerdal Foundation

Enrollment

1,020 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Inclusion Criteria2

  • 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 Criteria3

  • 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

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Interventions

BEHAVIORALFamily 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.

BEHAVIORALStandard 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


Locations(2)

Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital

Mek'ele, Tigray, Ethiopia

Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital

Mek'ele, Tigray, Ethiopia

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NCT07364903