NCT03292562已完成不适用
A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation - a Feasibility Study
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年9月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Number of Days on NCPAP or Mechanical Ventilation
研究概览
简要总结
The purpose of this study is to determine if among infants <30 weeks gestational age on nasal continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning off CPAP when compared to discontinuing CPAP without weaning pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 infants < 30 weeks by dates, on NCPAP therapy, on caffeine 10mg/kg daily
- •Meet CPAP stability criteria for ≥ 12hours (CPAP 6 cm water (H2O), FiO2 </=0.25 and stable (to maintain sats 85-95%), Respiratory rate consistently less than 60, Mild to no subcostal/intercostal retractions, No Apnea or bradycardia event that requires bag mask ventilation, Less than 3 apnea/brady/desat episodes in any 1 hour period for previous 6 hours, Tolerated time off CPAP during routine CPAP care (~15 min)
排除标准
- •Major congenital anomalies including congenital heart disease
- •Anomalies that prevent discontinuation of NCPAP
- •Undergoing current evaluation for and/or treatment of sepsis
结局指标
主要结局
Number of Days on NCPAP or Mechanical Ventilation
时间窗: from randomization until 28 days post-randomization
Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.
次要结局
- Number of Participants Who Failed to Wean Off NCPAP(from randomization until discharge (about 92 days))
- Duration of Endotracheal Ventilation(from randomization until 28 days post-randomization)
- Length of Hospital Stay(from admission to hospital until discharge (about 92 days))
- Number of Participants Who Developed Necrotizing Enterocolitis(from randomization until discharge (about 92 days))
- Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth(from randomization until discharge (about 92 days))
- Number of Participants Who Developed Bronchopulmonary Dysplasia(from randomization until discharge (about 92 days))
- Number of Participants Who Developed Air Leak Disorders(from randomization until discharge (about 92 days))
研究者
Amir Mustafa Khan
Professor
The University of Texas Health Science Center, Houston
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Trial of Weaning of Nasal Continuous Positive Airway Pressure (CPAP)Preterm NeonatesNCT01215591Maimonides Medical Center56
已完成
不适用
Comparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm InfantsRespiratory Distress SyndromeNCT02126501Maimonides Medical Center70
已完成
不适用
Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature InfantsPrematurityRespiratory Distress Syndrome, InfantNCT01721629Aarhus University Hospital380
尚未招募
不适用
Nasal Problems in Neonates and Infants Subjected to CPAPContinuous Positive Airway PressureNCT06557915Sohag University30
终止
2 期
A Trial of Infant Flow Biphasic Nasal Continuous Airway Pressure (NCPAP) Versus Infant Flow NCPAP for the Facilitation of Extubation in Infants </= 1250 GramsInfant, Premature, DiseasesApnea of PrematurityBronchopulmonary DysplasiaNCT00308789Mount Sinai Hospital, Canada136