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

Official title

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

Overview

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?

Interventions

• 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

Primary outcome measures

• Length of hospital stay [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 outcome measures (7)

• Survival at discharge [Time frame: Starting from date of admission to the date of discharge within the first 28 days of the neonate's life]
• Daily weight gain [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]
• Time to initiate breastfeeding after admission [Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life]
• Time to initiate skin-to-skin after admission [Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life]
• The number of days on Antibiotics [Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life]
• Score for parental stress monitoring scale [Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life]
• Discharge readiness score on the day of the discharge [Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Ethiopia · 2 centers

• Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital — Mek'ele
• Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital — Mek'ele

Publications

• Kahsay ZH, Medhanyie AA, Mariam DH, Ersdal HL, Rettedal S. Feasibility of implementing family-integrated newborn care for hospitalised preterm and low birthweight infants in newborn care units of Ethiopia: a mixed-methods design. BMJ Open. 2025 Jan 21;15(1):e093377. doi: 10.1136/bmjopen-2024-093377. PMID 39842933

Identifiers

NCT: NCT07364903 · LaerdalFoundation

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗