DRKS00023438
Completed
Not Applicable
Influence of non-invasive positive pressure ventilation versus nasal high-frequency oscillation ventilation on parameters of oxygenation and ventilation in premature infants in the weaning phase after respiratory distress syndrome
Menschen für Kinder e.V.0 sites24 target enrollmentMay 11, 2021
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- P22.0
- Sponsor
- Menschen für Kinder e.V.
- Enrollment
- 24
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Premature babies with a gestational age \<32 weeks of gestation and a birth weight \<1500 g, who are treated in the neonatal intensive care unit of the University Hospital Giessen and are at least 72 hours old.
- •2\. Requirement of non\-invasive ventilation (CPAP / NIPPV.
- •3\. FiO2 under CPAP / NIPPV 21 % \- 60% with a PEEP of 5\-8 cmH20
- •4\. At least 4 hypoxemias (\<80% SpO2\) and / or apneas / bradycardias in the 12 hours prior to study entry.
- •5\. In the 12 hours prior to study entry, the number of intervention\-requiring events (defined as SpO2 \<70% for\> 1min or heart rate \<100 / min for\> 30 seconds) does not lead to an escalation of the non\-invasive ventilation.
- •6\. Written consent of the legal guardian is given.
Exclusion Criteria
- •1\. Premature babies and newborns with severe malformations that significantly impair respiratory regulation (severe CNS malformations), lung function (e.g. pulmonary hypoplasia, acute extra\-alveolar air such as pneumothorax and pulmonary interstitial emphysema, diaphragmatic hernias) or the circulatory function (congenital cyanotic heart disease, septic shock).
- •2\. Postnatal age \<72 hours of life (often acute deterioration in the early phase of a respiratory distress syndrome and to protect the minimal handling principle in the critical phase to prevent intraventricular bleeding).
- •3\. Start of treatment for an acute clinical infection \<72 hours before study entry.
- •4\. FiO2 under CPAP / NIPPV\> 60% and / or PEEP\> 8cmH20\.
- •5\. Escalation of non\-invasive ventilation in the 12 hours before study entry due to the number of intervention\-requiring events (defined as SpO2 \<70% for\> 1 min. or Heart rate \<100 / min. for\> 30 seconds).
- •6\. Planned blood transfusion or surgery during the study phase.
Outcomes
Primary Outcomes
Not specified
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