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临床试验/NCT01939067
NCT01939067撤回1 期

Pulmonary Mechanics in Preterm Infants Treated With Heated Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure.

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
1 期
状态
撤回
试验地点
2
主要终点
Pulmonary mechanics and chest wall asynchrony measures.

研究概览

简要总结

This study is designed to evaluate the effect of heated humidified high flow nasal cannula (HHHFNC) as compared to noninvasive nasal continuous positive airway pressure (NCPAP) on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support.

详细描述

Respiratory distress and the need for respiratory support continues to be a common problem for preterm infants. Presence of the breathing tube and duration of respirator provided breaths have been shown to be associated with increased risk for secondary lung injury and subsequent development of chronic lung disease of prematurity. Early application of noninvasive nasal continuous positive airway pressure (NCPAP) has been shown to be an effective, non-invasive, mode of respiratory support in preterm infants and to be associated with a lower incidence of chronic lung disease. A recently published large randomized multicenter study concluded that, among infants born at 28 weeks and longer gestation, heated humidified high flow nasal cannula (HHHFNC) had similar clinical efficacy and safety as compared to NCPAP. Both NCPAP and HHHFNC are currently used to assist infants with breathing problems.

This study is designed to evaluate the effect of HHHFNC as compared to NCPAP on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support. In this study, infants will remain on the assigned treatment of either NCPAP or HHHFNC until they require more support as provided by a respirator or until a treatment cross-over from NCPAP to HHHFNC, or the reverse, as decided by their attending physician. The infant's respiratory support will be managed according to his/her attending doctor as per accepted standards of care. A pulmonary function test will be performed twice weekly on each enrolled infant while receiving either NCPAP or HHHFNC support, followed-up by once weekly lung function measurements post respiratory support while infants are breathing only room air until discharge.

研究设计

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

入排标准

年龄范围
2 Hours 至 72 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Birth weight greater than or equal to 1000 grams.
  • Gestational age at birth between 28 weeks and 37 weeks (28 0/7 to 37 6/7 weeks inclusive).
  • Candidate for non-invasive respiratory support as a result of:
  • An intention to manage the infant with non-invasive (no endotracheal tube) respiratory support.
  • An intention to extubate an infant being managed with intubated respiratory support to non-invasive respiratory support.
  • Subjects must have a guardian or acceptable surrogate capable of giving consent on his/her behalf.

排除标准

  • Birth weight less than 1000 grams.
  • Estimated gestation at birth less than 28 weeks or greater than 37 6/7 weeks.
  • Active air leak syndrome.
  • Subjects will not be eligible if they are not considered viable.
  • Infants with abnormalities of the upper and lower airways
  • Infants with significant abdominal or respiratory malformations .

结局指标

主要结局

Pulmonary mechanics and chest wall asynchrony measures.

时间窗: 2 years

Pulmonary mechanics measures consisting of dynamic lung compliance, airway resistance, and work of breathing and chest wall asynchrony measures consisting of thoracoabdominal asynchrony, labored breathing index and rib cage to abdominal phase relation during the total breath are measured in preterm infants treated with HHHFNC and compared to the same measurements in preterm infants treated with NCPAP.

次要结局

  • Duration of respiratory support or oxygen use up to the time of discharge from the NICU.(2 years)
  • The incidence of potential adverse outcomes associated with HHHFNC or NCPAP.(2 years)
  • Time needed to establish full enteral feeds(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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