Journal of Clinical Trials
Open Access

Abstract

Nasal Bilevel Versus Continuous Positive Airway Pressure in Preterm Infants: A Randomized Controlled Trial

Teresa Aguiar, Israel Macedo, Olga Voutsen, Pedro Silva, José Nona, Carina Araujo, Joana Imaginário, Antonio Mauricio, Rosalina Barroso, Teresa Tomé and Helena Carreiro

Objective: We designed a study with a primary objective of comparing the effectiveness of nasal continuous positive airway pressure (nCPAP) versus bi-level CPAP (BiPAP) as the primary mode of non-invasive ventilation in preterm newborns. The primary outcome was need for invasive ventilation in the first 120 hours of life. The secondary objective was to compare these two groups regarding duration of non-invasive ventilation, use of surfactant, incidence of pneumothorax, bronchopulmonary dysplasia (BPD), peri and intraventricular haemorrhage (PIVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), sepsis, length of hospitalisation and mortality.
Methods: Prospective, multicentre clinical trial enrolling 220 neonates born at 27 to 32+6 weeks of gestation randomly assigned at birth for either CPAP or BiPAP.
Results: One hundred and nine neonates received NCPAP and 111 BiPAP. Invasive ventilation was needed in 18.3% in the CPAP group and 14.4% in the BiPAP group. This difference was not statistically significant. However, when stratifying the groups regarding gestational age (GA), we found a tendency favouring BiPAP in subgroup of 30 to 32+6 weeks. There was no difference regarding the secondary outcomes, except for an increase in NEC in the CPAP group. Multivariate analysis demonstrated a significant association between absence of premature rupture of membranes and the need of invasive ventilation within the first 120 hours of life, independently on the assigned mode of non invasive ventilation.
Conclusion: BiPAP and CPAP are both effective and safe as a primary mode of ventilation in preterms between 27 and 32+6 weeks without important complications. In a subgroup of 30 to 32+6 weeks of gestation a better outcome using BiPAP was observed.