A Randomised Trial of Umbilical or Peripheral Catheter Insertion for Preterm Infants on NICU Admission
试验速览
- 阶段
- 不适用
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Core (rectal) temperature 2 hours after birth
研究概览
简要总结
Preterm infants are at risk of hypothermia following delivery and in the first few hours of life. Hypothermia in extremely low birth weight infants' is an independent risk factor for death. These infants' are at additional risk of hypothermia when they undergo procedures such as central catheter insertion following admission.
The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.
详细描述
Hypothermia is an independent risk factor for death in preterm newborns.(1) Despite measures to improve temperature in preterm newborns in the delivery room (DR), hypothermia on admission to the neonatal intensive care unit (NICU) at NMH is common. In a cohort of infants < 32 weeks' gestation born at NMH in 2019, 54% of infants had a rectal temperature < 36.5 oC on admission to the NICU.(2)
Many preterm infants have procedures performed soon after admission to the NICU; in 2019, 98% of infants born before 29 weeks' gestation at NMH had an umbilical venous catheter inserted. This may/often involve(s) prolonged periods of handling and potential exposure to cold.
The investigators prospectively studied a cohort of 26 infants < 32 weeks who had invasive procedures within 3 hours of birth performed in the NICU at NMH between November 2018 and June 2019. Almost three-quarters [19/26 (73%)] had an abnormal temperature at the beginning of the procedure; and 17/26 (65%) had an abnormal temperature at the end of the procedure. Only 3 (11%) infants maintained a normal temperature throughout the procedure. Perhaps more concerning is the severity of the hypothermia observed; 13 (50%) infants had a temperature < 36.0oC before and 11 (42%) after the procedure. The median duration of procedure was 53 (37, 73) minutes.(3)
The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 60 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •inborn infants admitted to the NICU with;
- •gestational age < 29 weeks (up to 28+6 weeks) OR
- •birth weight < 1250g.
排除标准
- •end of life (palliative) care
- •large abdominal wall defects
- •imperforate anus.
结局指标
主要结局
Core (rectal) temperature 2 hours after birth
时间窗: 2 hours
Core (rectal) temperature 2 hours after birth
次要结局
- Complications of line insertion/placement(10 days)
- Number of peripheral line attempts(up to 24 hours)
- Blood stream infections (CRBSI)(up to 16 weeks)
- Number of x-rays performed in first 24 hours(24 hours)
- Blood sampling in first 24 hours(24 hours)
- Number of blood transfusions during hospital stay(up to 26 weeks)
- PICC line insertion in the first 7 days of life(7 days)
- Intubation + Ventilation(Up to 3 days)
- Necrotizing enterocolitis (Bell's staging)(Up to 3 months)
- Periventricular leukomalacia(Up to 6 months)
- Axillary temperature at the end of the procedure(up to 24 hours)
- Time to completion of procedure (incubator roof down, portholes closed and hands off)(up to 24 hours)
- Mean difference in axillary temperature from admission to end of procedure(up to 24 hours)
- Number (%) of infants in whom PIVC as first point of access was unsuccessful (nothing was infused through the line)(24 hours)
- Time to first intravenous infusion starting (PN / dextrose / antibiotics / caffeine)(up to 24 hours)
- Number (%) infants that have umbilical catheters inserted during their admission(up to 24 hours)
- Number (%) lines used without repositioning(up to 24 hours)
- Number (%) of low lying umbilical venous catheters(up to 24 hours)
- Number (%) of infants' in whom attempted placement of an umbilical line was not successful(up to 24 hours)
- Inotropes administered in the first 72 hours of life(3 days)
- Number (%) lines repositioned(up to 24 hours)
- Number of blood tests in 72 hours(3 days)
- Peripheral arterial line insertion in the first 7 days of life(7 days)
- Surfactant administration(up to 3 days)
- Intraventricular Haemorrhage (Papile classification)(Up to 6 months)
- Chronic lung disease(Up to 3 months)
- In hospital mortality(Up to 6 months)