Randomised crossover trial of different nasal support systems for the treatment of apnea of prematurity
Not Applicable
Recruiting
- Conditions
- P28.4Other apnoea of newborn
- Registration Number
- DRKS00005387
- Lead Sponsor
- niversitätsklinik für Kinder- und Jugendmedizin, Abt. IV Neonatologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
Gestational age at birth = 34 0/7 weeks; age at study performance = 38 0/7 weeks; persistent apneas despite administration of caffeine; apnea-score = 6 (a score used routinely at our neonatal intensive care unit to monitor the frequency and severity of apneas); parental approval and written informed parental consent
Exclusion Criteria
Congenital severe dysplasia (e.g. congenital heart defect, chromosome abnormality); symptomatic apnea due to sepsis, epileptic seizure, hypoglycemia or intracerebral haemorrhage; neuromuscular, muscular or skeletal disease; necessity of changing the dosis of caffeine or doxapram; necessity of intubation and mechanical ventilation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Combined rate of intermittent hypoxia (SpO2 <80%) and bradycardia (pulse rate <80/min.) per hour. The recording of aterial oxygen saturation is carried out using a Vitaguard 300 (Getemed, Teltow, Germany) monitor for a period of 48 hours (each intervention for 8 hours, then the last one for another 24 hours).
- Secondary Outcome Measures
Name Time Method Mean FiO2, mean tcPCO2 and change of abdominal girth during the particular 8-hour interval (documentation through nursing staff).