Effects of different inspiratory times on oxygenation and ventilation parameters in preterm infants with frequent fluctuations in arterial oxygen saturations - a randomized controlled trial
- Conditions
- Apnea of Prematurity
- Registration Number
- DRKS00023923
- Lead Sponsor
- Abteilung Allgemeine Pädiatrie und Neonatologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time (percentage) the preterm infants spent within his specific SpO2- target range.
- Secondary Outcome Measures
Name Time Method