Abstract
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.
Highlights
Since the 1970’s, non-invasive ventilation (NIV) in newborns with nasal CPAP has been increasingly used
Bilevel CPAP (BiPAP) provides two levels of positive end expiratory pressure (PEEP) during the respiratory cycle of the patient with a frequency and a duration determined by the physician
BiPAP should allow a higher alveolar recruitment, a higher residual function capacity and a reduction in breath working when compared to nasal CPAP (nCPAP)
Summary
Since the 1970’s, non-invasive ventilation (NIV) in newborns with nasal CPAP (nCPAP) has been increasingly used. Nasal CPAP establishes a continuous distension pressure (CDP) throughout the respiratory cycle, which is fundamental to restore the functional residual capacity, reduce working of breath and stabilize the respiratory pattern [3,4]. It is becoming widely used in the delivery room because if it is applied from the first breaths, it will help in obtaining lung volume stabilization [5]. BiPAP should allow a higher alveolar recruitment, a higher residual function capacity and a reduction in breath working when compared to nCPAP It hasnt yet been proved in clinical studies. Recent meta-analysis made by Schmolzer [11] and Fischer [12] demonstrated that there is a statistically significant advantage in the use of non-invasive ventilation regarding death and BPD
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