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临床试验/NCT02126501
NCT02126501已完成不适用

Randomized Control Trial of Weaning NCPAP From Preterm Infants: Sudden Wean Versus Weaning by Gradually Decreasing Pressure

Maimonides Medical Center1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Success of weaning on first trial off NCPAP

研究概览

简要总结

To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in premature babies born between 26 and 32 weeks

详细描述

To study the weight and the post menstrual age (PMA) at the time of NCPAP wean utilizing the method of sudden wean as compared to gradual wean.

Methods: A prospective randomized trial was conducted comparing sudden weaning with gradual weaning from NCPAP in neonates with gestational age between 26 and 32 weeks. The patients were randomized to one of the two methods of weaning from NCPAP and their success was compared

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
26 Weeks 至 32 Weeks(Child)
性别
All
接受健康志愿者
否

入选标准

  • •All neonates born 26 to 32 weeks of gestational age

排除标准

  • •Those with severe congenital anomalies and chromosomal defects including congenital heart disease, neurological malformations, chest and airway abnormalities and lung hypoplasia

研究组 & 干预措施

Sudden wean

No Intervention

When ready Nasal Continuous Positive Airway Pressure (NCPAP) will be removed from the neonate

Gradual pressure wean

Active Comparator

NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided

干预措施: Gradual pressure wean (Other)

结局指标

主要结局

Success of weaning on first trial off NCPAP

时间窗: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks

次要结局

  • Weight and corrected GA when come off oxygen(when off supplemental oxygen expected average of 2 weeks)
  • Weight and corrected gestational age (GA) when neonates could come off NCPAP(Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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