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临床试验/NCT05547139
NCT05547139已完成不适用

Impact of Extended CPAP Utilization on Bronchopulmonary Dysplasia in Extremely Premature Infants: A Pilot Randomized Control Trial

Christiana Care Health Services2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年10月10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
20
试验地点
2
主要终点
Time to reach 2L NC or room air

研究概览

简要总结

The purpose of this pilot study is to compare if keeping infants on CPAP (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately 2 pounds and 12 ounces) will decrease their degree of lung disease as compared to weaning their respiratory support to HFNC (high flow nasal cannula).

详细描述

There are two ways to help premature babies breathe. Both HFNC and CPAP are commonly used in our NICU. CPAP, which helps your baby breathe without a tube in their windpipe (intubation or ventilator), delivers oxygen and air by pressure through either small prongs in the nose or a nose mask, keeping your baby's airways open. HFNC provides heated and humidified oxygen and air by small prongs in the nose that does not use high pressure to the airways. Our goals are to reduce long term complications such as lung disease of prematurity, also called Bronchopulmonary Dysplasia (BPD). BPD causes "lung damage/scarring, need for a ventilator or oxygen, brain/neurological impairment etc. In recent years, HFNC has become a common choice for care. There is no clear agreement in previous research which way may be best to reduce BPD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
22 Weeks 至 30 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • babies born at <30 weeks' gestation
  • babies who are extubated to non-invasive ventilation by 32 weeks postmenstrual age

排除标准

  • babies born at <30 weeks' gestation
  • requiring less than 2L NC at birth or
  • those who are extubated after 32.0 weeks' postmenstrual age
  • congenital anomalies
  • skeletal disorders
  • neuromuscular disorders
  • genetic syndromes

结局指标

主要结局

Time to reach 2L NC or room air

时间窗: up to 3 months

The primary outcome is time (in days) to reach 2L nasal cannula or room air

次要结局

  • Compliance to protocol and balancing measures(up to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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