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

Laerdal Foundation

Status: Enrolling

Conditions: Family Involvement/Empowerment; Family-centered Care; Intensive Care Units, Neonatal; Family Integrated Newborn Care

Treatments: Behavioral: Standard medical treatment; Behavioral: Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates

Study type: Interventional

Funder types: Other

Identifiers

NCT07364903

LaerdalFoundation

Details and patient eligibility

About

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.

Full 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?

Enrollment: 1,020 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,020 participants in 2 patient groups

FINC arm

Experimental group

Description:

This arm includes the family of the neonates assigned to the experimental group, and they will receive a FINC intervention. The FINC intervention, families of preterm and low-birth weight neonates aged 0-28 days will be trained, educated, and encouraged to get involved in the newborn care targeted to their neonates.

Treatment:

Behavioral: Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates

Non-FINC arm

Active Comparator group

Description:

This arm includes the families of the neonates assigned to the comparator group, who will receive conventional or standard care. No special effort that the routine care will be provided to integrate the family into the care targeted to the preterm and low-birth-weight neonates

Treatment:

Behavioral: Standard medical treatment