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临床试验/DRKS00023923
DRKS00023923招募中4 期

Effects of different inspiratory times on oxygenation and ventilation parameters in preterm infants with frequent fluctuations in arterial oxygen saturations - a randomized controlled trial - Not applicable

Abteilung Allgemeine Pädiatrie und Neonatologie0 个研究点目标入组 24 人开始时间: 2020年12月28日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
one 至 one(—)
性别
All

入选标准

  • 1. premature infants (birth weight <1500g) who are treated in the neonatal intensive care unit or the intermediate care area
  • 2. need of non-invasive ventilation (CPAP/NIPPV)
  • 3. at least 4 hypoxemias (< 80% SpO2) or 4 apneas/bradycardias in 8 hours before study entry
  • 4. written informed consent from legal guardians has been obtained

排除标准

  • 1. premature and newborn infants with severe malformations that significantly affect respiratory regulation (severe CNS malformations), pulmonary function (e.g., pulmonary hypoplasia, acute extraalveolar air such as pneumothorax and pulmonary interstitial emphysema, diaphragmatic hernias), or circulatory function (congenital cyanotic cardiac disease, severe septic shock)
  • 2. postnatal age <120h (often acute deterioration in the early phase of respiratory distress syndrome and to protect the minimal handling principle in the critical phase to prevent intraventricular hemorrhage)
  • 3. clinical sepsis (defined as CRP level >10mg/l) with or without circulatory insufficiency, or positive blood culture
  • 4. Anticipated blood transfusion during the study phase

研究者

发起方
Abteilung Allgemeine Pädiatrie und Neonatologie

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