Overview
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.
Description
Treatment failure is defined as any of the following:
- FiO2>0.6 to maintain SpO2>88%
- Respiratory acidosis (pH<7.2, pCO2>65 mmHg)
- recurrent apnea (>4 episodes/h) or apnea requiring bag and mask ventilation
- Silverman Andersen respiratory severity score (SAS score) ≥6 and does not improve by > 20% within 4-8 hours
Secondary endpoints:
- Mortality rate
- Intubation rate
- Late onset sepsis (LOS) rate
- Treatment duration
- Complication rates:
Pneumothorax rate Bronchopulmonary dysplasia (BPD) Necrotizing enterocolitis (NEC) Persisting ductus arteriosus (PDA) Intraventricular hemorrhage (IVH) Retinopathy of prematurity (ROP)
Nasal trauma:
- I° - nasal/septal redness
- II° - nasal/septal redness + indent
- III° - nasal/septal redness + indent + skin breakdown
Abdominal distension:
- Visible abdominal distension (defined by attending clinician) AND one of the
- following
- Feeding intolerance (defined by clinician) OR
- >3 desaturation episodes or >20% FiO2 increase in 1 hour after feed.
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
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Major congenital anomalies
- Cardiovascular instability
- Consent refused or not provided