DRKS00023923
Recruiting
Phase 4
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 sites24 target enrollmentDecember 28, 2020
ConditionsApnea of Prematurity
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Apnea of Prematurity
- Sponsor
- Abteilung Allgemeine Pädiatrie und Neonatologie
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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