Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 366
- 试验地点
- 36
- 主要终点
- Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)
研究概览
简要总结
The objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants.
The hypothesis of this study is that length of hospital stay (from birth to discharge) will be decreased among moderate preterm infants weaned from an incubator to an open crib at a lower versus higher weight, 1600g vs. 1800g.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 29 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age 29 0/7 to 33 6/7 weeks at birth
- •Birth weight less than 1600 grams
- •Greater than 48 hours of age
- •Current weight less than 1540 grams
- •In an incubator
排除标准
- •Receiving phototherapy
- •Receiving respiratory support (including CPAP, ventilation, HFNC > 2 LPM)
- •Receiving blood pressure support
- •Designated for transfer to referral hospital while in incubator
- •Known major congenital or chromosomal anomaly
研究组 & 干预措施
Lower Weight (1600 grams)
Weaning from an incubator at a lower weight (1600 grams)
干预措施: Weaning from an incubator at a lower weight (1600 grams) (Procedure)
Higher Weight (1800 grams)
Weaning from an incubator at a higher weight (1800 grams)
干预措施: Weaning from an incubator at a higher weight (1800 grams) (Procedure)
结局指标
主要结局
Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)
时间窗: From birth through discharge
Number of days the infant stays in hospital after birth until discharge home (up to 120 days).
次要结局
- Readmission to the Hospital Within 1 Week of Discharge(Discharge through 1 week after discharge.)
- Length of Stay (LOS) Following Randomization to Hospital Discharge(From randomization through discharge.)
- Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)(From start of weaning from the incubator to crib through discharge (up to 120 days))
- Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)(Start of weaning from incubator through 36 weeks postmenstrual age (PMA))
- Growth Parameters: Weight at Status(Status (discharge, death, transfer to another facility, or 120 days))
- Growth Parameters: Length at Status(Status (discharge, death, transfer to another facility, or 120 days))
- Death Among Enrolled Infants(Status (discharge, death, transfer to another facility, or 120 days))
- Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)(Through completion of 2 weaning attempts)
- Growth Parameters: Head Circumference at Status(Status (discharge, death, transfer to another facility, or 120 days))
- Postmenstrual Age (PMA) at Discharge(Discharge)
- Transferred to a Non-Network Hospital(Status (discharge, death, transfer to another facility, or 120 days))