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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorLaerdal Foundation

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 volunteers

Qualifiers

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

Design model

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

    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.

  • 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

Treatment groups

1,020 Participants
are divided into 2 treatment groups
Group A: FINC armExperimental treatment 1 intervention
Group B: Non-FINC armActive comparator 1 intervention

Trial outcomes

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

Time frame
The period from the date of admission to the date of discharge is within the first 28 days of neonat's life.

Secondary outcomes

1

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.

Time frame
Starting from date of admission to the date of discharge within the first 28 days of the neonate's life
2

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 frame
Starting from the date of admission up to the date of discharge and assessed in the first 28 days of the neonate's life
3

Time to initiate breastfeeding after admission

The time the breastfeeding of the neonate is initiated for the first time since admission

Time frame
Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
4

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)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laerdal Foundation

Lead sponsor

University of Stavanger

Sponsor institution

Mekelle University

Collaborator

Addis Ababa University

Collaborator