About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates
BehavioralThe 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.
Standard medical treatment
BehavioralThe 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
Treatment groups
Trial outcomes
Primary outcomes
Length of hospital stay
It refers to the duration a neonate stays in the hospital for care, starting from admission to discharge home
Secondary outcomes
Survival at discharge
Survival status of the neonate at discharge, specified as alive, dead, or referred for higher-level care, or left against medical advice.
Daily weight gain
The net weight gain of a neonate each day (in grams/kg/day) in reference to the expected gain for the body mass
Time to initiate breastfeeding after admission
The time the breastfeeding of the neonate is initiated for the first time since admission
Time to initiate skin-to-skin after admission
The first time skin-to-skin is initiated for the neonate, since the date of admission to the Neonatal Intensive Care Unit (NICU)
Sponsors and contacts
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Laerdal Foundation
Lead sponsor
University of Stavanger
Sponsor institution
Mekelle University
Collaborator
Addis Ababa University
Collaborator