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临床试验/NCT05260424
NCT05260424已完成不适用

Predictors for Nasal Intermittent Positive Pressure Ventilation Failure for Premature Infants With Respiratory Distress Syndrome

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 397 人开始时间: 2020年12月1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
397
试验地点
1
主要终点
Risk of intubation in the first 72 hours in premature babies

研究概览

简要总结

Non-invasive respiratory support methods have been widely used in premature babies with respiratory distress syndrome (RDS) which has changed the basic management of premature babies in the early period. According to the 2019 European Guidelines on RDS management, early nasal CPAP is recommended as first-line therapy in infants <30 weeks of age who are at risk of RDS who do not require mechanical ventilation (MV). However, some of the premature babies have faced non-invasive ventilation failure. Remarkably, infants who experience non-invasive ventilation failure are at increased risk of death, pneumothorax, intraventricular hemorrhage, and bronchopulmonary dysplasia (BPD), among other morbidities. In non-invasive ventilation failure, although demographic factors such as small gestational age, low birth weight, and male gender play a role, it has been suggested that surfactant deficiency may also play an important role. The most frequently reported risk factor in predicting non-invasive failure in studies is the fraction of inspiring oxygen during the first hours of life. In addition, positive end-expiratory airway pressure (PEEP) required for patient stabilization was found to be a potential predictor. However, there are still limited data to predict non-invasive ventilation failure. "Which newborns are at high risk for non-invasive ventilation failure?" and "When should the surfactant be applied?". The study is a single-center, prospective study to evaluate prognostic factors, and most importantly to define the FiO2 threshold, which is an indicator of possible non-invasive ventilation failure in infants supported with nasal intermittent positive pressure ventilation.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • <32 weeks preterm babies
  • Those who have received nasal intermittent positive pressure ventilation

排除标准

  • Babies born> 32 weeks
  • Babies with congenital anomalies
  • Babies who have intubated in the delivery room
  • Babies whose parents refuse to participitate

结局指标

主要结局

Risk of intubation in the first 72 hours in premature babies

时间窗: 2 year

To determine the risk of intubation in the first 72 hours of life in premature babies less than 32 weeks of gestation who have supported with nasal intermittent positive pressure ventilation

次要结局

  • Looking for early predictors,(2 year)
  • To describe the incidence and early precursors of non-invasive ventilation failure.(2 year)
  • morbidity and mortality(2 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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