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临床试验/NCT01440647
NCT01440647已完成不适用

Nasal Intermittent Positive Pressure Ventilation Allows Early Extubation In Infants Less Than 28 Weeks Gestation: A Pilot Study

Women and Infants Hospital of Rhode Island2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2007年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Number of Days Being Intubated

研究概览

简要总结

Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube is associated with injury to the lungs. Currently, a premature baby has to be ventilated through an endotracheal tube until he/she can fully breathe independently. In the current study, in order to shorten the time with an endotracheal tube, we utilized an alternative, less invasive ventilation procedure, nasal intermittent positive pressure ventilation (NIPPV). This procedure provides help with breathing, but requires only nasal, not endotracheal tubes. We hypothesized that NIPPV might help babies breathe, at an early stage in their recovery, when they could not breathe independently yet. Thus, by switching babies at this early stage from a regular respirator to NIPPV, we should be able to shorten the use of an injurious endotracheal tube.

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
— 至 48 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age 24 wks and 0 days through 27 wks and 6 days by obstetric criteria.
  • Infants who are intubated for respiratory distress and received surfactant within 48 hrs of life.
  • Infants whose ventilator settings are: ventilatory rate ≥ 26 breaths per minute. If the baby is on the high frequency oscillatory ventilator (HFOV) settings are MAP(mean airway pressure) ≥ 9, amplitude ≥ 2xMAP and frequency ≤ 13 Hertz.
  • Infants who have never been previously extubated.

排除标准

  • Infants enrolled in competing trials.
  • Participation refused by parent/attending physician/ parent unavailable for consent.
  • Infants with any major congenital abnormality.
  • Postoperative patients from any surgery.
  • Infants in extremis/decided upon not to receive intensive care.
  • Ventilator settings lower than the intervention group.

结局指标

主要结局

Number of Days Being Intubated

时间窗: 30 days from birth

次要结局

  • Percentage of Participants With Reintubation(0-7 days post-extubation)

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olga Sorina

Principal Investigator

Women and Infants Hospital of Rhode Island

研究点 (2)

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