Influence of CPAP versus high-flow nasal cannula on oxygenation and ventilation parameters in preterm infants after respiratory distress syndrome - a randomised clinical trial

niversitätsklinikum Gießen, Abteilung Allgemeine Pädiatrie und Neonatologie0 个研究点目标入组 74 人开始时间: 2024年3月22日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Premature infants (birth weight < 1.500 g) treated in the neonatal intensive care unit or the intermediate care unit
•2. FiO2 under CPAP/NIPPV < 0.3 with PEEP = 5 mmHg
•3. Need of non-invasive ventilation (CPAP/NIPPV)
•4. At least 4 hypoxaemias (< 80% SpO2) or 4 apnoeas/bradycardias in 8 hours before study entry
•5. Less than > 2 irritable/intervention events/4h (defined as SpO2 < 80% for > 1 min or heart rate < 100/min for > 30 seconds) before study entry
•6. Written informed consent from the legal guardians has been obtained

•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 cynaotic cardiac disease, severe septic shock)
•2. Postnatal age < 120 h (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 > 10 mg/l) with or without circulatory insufficiency or positive blood culture
•4. FiO2 under CPAP/NIPPV > 0.3 with PEEP > 5 mmHg
•5. Significant apnoea-bradycardia-syndrome (> 2 irritable/intervention events/4h = SpO2 < 80% for > 1 min or heart rate < 100/min for > 30 seconds) before study entry
•6. Anticipatory blood transfusion during the study phase

发起方

niversitätsklinikum Gießen, Abteilung Allgemeine Pädiatrie und Neonatologie