Effectiveness of Implementing Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates in Resource-limited Settings; Quasi-experimental Design
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Laerdal Foundation
- 入组人数
- 1,020
- 试验地点
- 2
- 主要终点
- Length of hospital stay
概览
简要总结
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.
详细描述
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:
- 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?
- Was the uptake of implementation of the FINC intervention for preterm and low-birth-weight neonates acceptable?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
FINC arm
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.
干预措施: Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates (Behavioral)
Non-FINC arm
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
干预措施: Standard medical treatment (Behavioral)
结局指标
主要结局
Length of hospital stay
时间窗: The period from the date of admission to the date of discharge is within the first 28 days of neonat's life.
It refers to the duration a neonate stays in the hospital for care, starting from admission to discharge home
次要结局
- Survival at discharge(Starting from date of admission to the date of discharge within the first 28 days of the neonate's life)
- Daily weight gain(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(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(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(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(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(Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life)
研究者
Znabu Hadush Kahsay
Principal Investigator
University of Stavanger