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临床试验/NCT01093495
NCT01093495已完成不适用

A Randomized Controlled Trial on Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

Mansoura University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年1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
60
试验地点
1
主要终点
Duration of oxygen use

研究概览

简要总结

There is little data published concerning the best approach to nasal continuous positive airway pressure (nCPAP) weaning. Potential complications associated with prolonged nCPAP therapy include gastric distension, nasal trauma,pneumothorax,agitation and nosocomial infection. Moreover, Infants on nCPAP may also require more intensive nursing care and the use of extra equipment. Therefore, minimizing the amount of time that a patient requires CPAP may be beneficial. On the other hand, removing CPAP too early may lead to complications that include: increasing apnea, increased oxygen requirement, increased work of breathing, the need to re-start CPAP, and intubation and mechanical ventilation. Moreover, an experimental study have demonstrated an improvement in lung growth after the prolonged use of CPAP.

Nasal cannula (NC) flows at 1-2 L/min may also generate a positive pressure in the airway of preterm infants. The use of NC flow to generate positive airway pressure would minimize many of the application issues of nCPAP. However, NC systems used in neonates routinely employ gas that is inadequately warmed and humidified, limiting the use of such flows due to increased risk of nasal mucosa injury, and possibly increasing the risk for nosocomial infection.

The purpose of this randomized controlled trial is to evaluate the clinical impact of two methods for weaning preterm infants from nCPAP.

详细描述

The objective of this study is to test the null hypothesis that in preterm infants with gestational age of 28 to 36 weeks who are stable on CPAP pressure of 5 cmH2O and with oxygen concentrations (FiO2) <0.30, keeping these infants on CPAP or changing them to NC flow of 1-2 L/min will not make any difference in length of hospitalization, length of respiratory support and incidence of complications.

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
28 Weeks 至 36 Weeks(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Infants born greater than or equal to 28 weeks (28+0) and less than 37 weeks (36+6) gestation
  • •CPAP pressure of 5 cm H2O
  • •FiO2 requirement = or <0.30
  • •Clinically stable on these CPAP parameters for 24 hours pre-randomization:
  • •Respiratory rate less than 60
  • •No significant chest recession
  • •No apnea requiring bagging and/or
  • •Not more than 6 apneas requiring stimulation in the preceding 24 h.
  • •Average saturation > or = 87%
  • •Satisfactory ABG (pH> 7.25, PCO2 < 60, and Base deficit < -8)

排除标准

  • •Life threatening congenital anomalies
  • •Congenital cyanotic heart diseases
  • •Congenital airway or chest wall abnormalities
  • •Pulmonary hypoplasia
  • •Known or suspected to have a neuromuscular disorder
  • •Congenital neurological disorder, severe IVH (grade 3 or 4), PVL and hydrocephalus

研究组 & 干预措施

CPAP group

Experimental

Subjects in this group will continue receiving CPAP until no oxygen requirement for 24 hours, then will be weaned off CPAP completely as long as they tolerate. CPAP will be re-instituted if subjects meet failing criteria. Another trial off CPAP will start 24 hours after failure and/or after being on 21% for 24 hours. CPAP will be weaned off directly to room air at all times.

干预措施: CPAP (Device)

Nasal Cannula Group

Experimental

Subjects will be weaned from CPAP (when FiO2 <0.30) to Nasal cannula (2 L/min) with whatever FiO2 they need until they are off oxygen and NC completely. However, if these infants fail on NC they will be put back to nCPAP. Infants will then be maintained on CPAP until stable on CPAP-30% for 24 hours. Infants will be tried for another weaning using NC. So, infants assigned to NC will be weaned only through NC. CPAP will be used only for stabilization in between trials if needed.

干预措施: Nasal Cannula (Device)

结局指标

主要结局

Duration of oxygen use

时间窗: 3 months

The number of days for oxygen use from the start of randomization until hospital discharge will be recorded.

次要结局

  • Length of respiratory support(3 months)

研究者

申办方类型
Other

研究点 (1)

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