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.
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?
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,020
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.
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
Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital
Mek'ele, Tigray, Ethiopia
RECRUITINGMekelle General Hospital, Wukro General Hospital and Adigrat General Hospital
Mek'ele, Tigray, Ethiopia
NOT_YET_RECRUITINGLength 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.
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
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
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
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
The number of days on Antibiotics
The total number of days the neonate received antibiotics for being suspected or diagnosed with sepsis
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
A score for the parental stress monitoring scale, which consists of eight items in a five-point Likert scale, with scores ranging from a lower score (1= Not stressful at all) to a higher score (5= Extremely stressful).
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
The score for the discharge readiness scale, consisting of eight items in a five-point Likert scale, to assess parents' readiness at the time of discharge. The score level ranges from a lower score (1= Extremely low confidence) to a higher score (5= Extremely high confidence).
Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life
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