Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.

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.

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.