The Baby-Saver Kit: Development and Evaluation of a Novel Device for Affordable Neonatal Resuscitation in a Low-income Region in Africa
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change from 10 minutes in post-resuscitation temperature at 30 minutes
研究概览
简要总结
To examine the usability, safety and acceptability of the BabySaver kit: a novel device for neonatal resuscitation in a low-income region in Africa
详细描述
The BabySaver kit will be used for any delivery in which the baby requires resuscitation according to the hospital policy, national guidelines(Ministry of Health, 2016) and WHO policy(World Health Organization, 2014)
The target sample size for observation will be 30 babies requiring resuscitation at Mbale Regional Referral Hospital Delivery suite.
The researchers will observe midwives and mothers during the process of resuscitation. This will be a non-participant observation. The researchers will collect data on: demographics, the timing of cord clamping, time to establish ventilation, intervention provided on the kit, post-resuscitation temperature, need to move the baby to provide extra care, and notes of the ease of use or challenges experienced with the kit. The researchers will ask health workers for their views of the usability of the kit in comparison to the equipment in current use.
The researchers have developed a usability checklist to assess how health workers are using the BabySaver kit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •As this is the first delivery suite to use the kit in a clinical setting, we will include only low-risk babies in this study. Every low-risk birth that will need neonatal resuscitation will be selected and observations made for the use of the BabySaver resuscitation kit.
排除标准
- •High risk deliveries will be excluded, namely
- •babies born before 34 weeks' gestation,
- •babies with life threatening malformations or significant intrapartum asphyxia
结局指标
主要结局
Change from 10 minutes in post-resuscitation temperature at 30 minutes
时间窗: Between 10 and 30 minutes after birth
The researcher will measure post resuscitation temperatures at 10, 20 and 30 minutes afterbirth for babies not admitted to the neonatal unit after using the BabySaver.
Number of procedures performed to newborns while on the BabySaver kit
时间窗: at birth, upto 30 minutes
The researcher will list any resuscitation procedures or interventions provided to the newborns on the kit.
change from childbirth in post-resuscitation temperature at admission to Neonatal unit.
时间窗: Upon admission to Neonatal unit, up to 1 hour after birth
For babies admitted to the neonatal unit, the baby's temperature will be measured on admission to the Neonatal unit
次要结局
- Design assessments transcripts(uptown 2 months)
- change from birth in Apgar score at 5 minutes(upto 5 minutes)
- Demographic assessments(baseline)