About this trial
Primary objective: to evaluate safety and efficacy of two different non-invasive respiratory support modalities in preterm neonatal patients with respiratory distress syndrome.
Secondary objective is to compare different respiratory support mode performance in different gestational age groups.
Primary endpoint is treatment failure.
With this study, the following hypotheses will be tested:
Hypothesis 1: NIPPV has a lower failure rate compared to CPAP mode. Hypothesis 2: NIPPV complication rate is non-superior compared to CPAP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
gestational age (GA) between 22+0 and 34+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings).
Need of respiratory support (deemed by a clinician).
Disqualifiers
Major congenital anomalies
Cardiovascular instability
Consent refused or not provided
Trial design
Parallel
Treatments tested in this trial
NIPPV
Other interventionNIPPV * PEEP 6-8 cmH2O * PIP: 14-16 cmH2O * Tinsp: 0.3-0.5sec * \<28 weeks GA: 0.3 - 0.4 sec * \>28weeks GA: 0.4 - 0.5 sec * Rate: 20-35 breaths per minute.
CPAP
Other interventionCPAP pressure of 6-8 mmH2O
Treatment groups
Trial outcomes
Primary outcomes
Treatment failure
Need of intubation
Secondary outcomes
Secondary outcomes
Mortality rate
Secondary outcomes
Intubation rate
Secondary outcomes
Late onset sepsis (LOS) rate
Secondary outcomes
Treatment duration
Sponsors and contacts
Click on the lead sponsor to view all of their trials.