跳至主要内容
临床试验/NCT03592134
NCT03592134Unknown不适用

Choice and Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns < 30 Gestational Weeks

Hôpital Necker-Enfants Malades1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年2月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Maximal variation of esophageal pressure

研究概览

简要总结

Noninvasive respiratory supports (NRS), such as continuous positive airway pressure (CPAP), noninvasive ventilation, high flow nasal cannula (HFNC) or nasal oxygen (O2), are commonly used in preterm newborns hospitalized in neonatal intensive care unit. However, given the lack of validated criteria, clinicians usually choose the NRS according to clinical parameters and patients' comfort. Several studies have demonstrated the interest of the measurement of the work of breathing (WOB) to optimize the settings of NRS in children, but no study has already demonstrated the utility of WOB to optimize the settings of NRS in preterm infants. Therefore, the aim of this study is to measure the WOB during the utilisation of three different NRS (CPAP, HFNC, O2), in order to optimize the choice of the type and settings of NRS in a randomized group of 30 newborns born prematurely before 30 gestational weeks and still requiring NRS at 29 post conceptual weeks. Moreover, the investigators will compare in the newborns with the optimized NRS by WOB vs. a standard care control group (NRS type and settings determined as clinical routine): 1) the respiratory morbidity and mortality one month after the initial assessment, and at the time of hospital discharge (or transfer) or at 36 weeks of age corrected (whatever comes first), 2) the weaning time of the NRS, 3) the incidence and severity of broncho-pulmonary dysplasia (BPD) at 36 weeks of age corrected. Indeed, incidence of BPD is still around 40% in premature infants born before 28 gestational weeks. The hypothesis of the investigators' study is that the optimization of the type and settings of the NRS could reduce the weaning delay and contribute to reduce the incidence and severity of BPD in premature newborns.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
4 Weeks 至 6 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants born between 23 and 30 GA
  • Aged over 29 weeks of corrected age at the time of assessment and needing a non invasive respiratory support since at least 4 weeks of age

排除标准

  • Hemodynamic and/or neurologic instability
  • Invasive ventilation
  • Congenital cardiopathy and/or significant patent ductus arteriosus
  • Congenital pulmonary disease and/or other malformations

结局指标

主要结局

Maximal variation of esophageal pressure

时间窗: at participant inclusion day 1

Maximal variation of esophageal pressure will be compared for the different respiratory supports and the different settings

次要结局

  • occurrence of bronchopulmonary dysplasia at 36 Gestational age (GA)(From 2 to 7 weeks after participant's inclusion (day 1))
  • need for nutritional support(From 2 to 7 weeks after participant's inclusion (day 1))
  • definitive weaning delay(From 2 to 7 weeks after participant's inclusion (day 1))

研究者

发起方
Hôpital Necker-Enfants Malades
申办方类型
Other
责任方
Principal Investigator
主要研究者

Brigitte Fauroux

Professor

Hôpital Necker-Enfants Malades

研究点 (1)

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