Effectiveness of nCPAP for moderate preterm infants compared to BiPAP: A Randomized, Controlled Non‐Inferiority Trial

Abstract

Background: Bilevel positive airway pressure (BiPAP) has recently been used in preterm infants with respiratory distress as an alternative to nasal continuous positive airway pressure (nCPAP) because, theoretically, BiPAP is thought to be more effective than nCPAP. However, the results of some studies comparing nCPAP with BiPAP as the initial respiratory support were controversial. The aim of this study is to compare the clinical effectiveness and safety of nCPAP with BiPAP at gestational ages of 30 +0 to 34 +6 weeks. Methods: A total of 93 infants with gestational ages of 30 +0 to 34 +6 weeks, who presented with respiratory distress within 24 h after birth, were randomized to the nCPAP group or the BiPAP group. The primary outcome was the incidence of treatment failure with these two non-invasive respiratory support devices. Criteria for treatment failure included any of the following: respiratory acidosis (PaCO 2 >65 mmHg with pH <7.2), hypoxia (FiO2 >0.4), or apnea (>2-3 episodes of apnea/h). Results: There was no statistically significant difference in treatment failure between the two groups (P = 0.576). The risk difference comparing treatment failure rate between nCPAP and BiPAP groups was À4.7% (95% CI: À21.5-11.9). Conclusions: Nasal continuous positive airway pressure is not inferior to BiPAP as an initial management of respiratory distress in these premature infants. We therefore conclude that nCPAP can be used as an initial management for preterm infants at gestational age of between 30 and 35 weeks as a substitute for BiPAP.Key words bi-level positive airway pressure, moderate preterm infant, nasal continuous positive airway pressure, non-invasive ventilation, respiratory support. MethodsWe conducted a randomized, controlled, non-inferiority study at the tertiary care neonatal intensive care unit (NICU) of Korea University Ansan Hospital, Ansan city, Korea, from June 2012 to July 2015. A total of 93 neonates were enrolled and randomized to the nCPAP group (n = 46) or the BiPAP group (n = 47).

Efficacy of noninvasive respiratory support modes for primary respiratory support in preterm neonates with respiratory distress syndrome: Systematic review and network meta‐analysis

“…The differences in the findings between this NMA and Isayama et al's 10 might be due to the fact that while this NMA had included only noninvasive modalities of respiratory support and had excluded neonates requiring invasive MV, Isayama et al 10 had assessed interventions such as LISA, INSURE, nebulized surfactant, surfactant application through laryngeal mask airway and invasive MV in their NMA. Also, more recent studies that were published after Isayama et al's 10 meta‐analysis were included in the present analysis 39,40,52‐54 . The other reason might be the differences in the gestational ages of the neonates enrolled in Isayama et al 10 study and our study.…”

“…Also, more recent studies that were published after Isayama et al's 10 metaanalysis were included in the present analysis. 39,40,[52][53][54] The other reason might be the differences in the gestational ages of the neonates enrolled in Isayama et al 10 study and our study. While Isayama et al 10 included studies that have enrolled smaller neonates (mean gestational age of 29 weeks), ours had included neonates with a mean gestational of 31 weeks.…”

“…The electronic database search revealed a total of 9032 studies. After screening for suitability, 35 studies were included in the final synthesis 23‐57 . The PRISMA flow diagram is depicted in Figure 1.…”

“…Overall, 13 studies 25,28,30,32,33,37,[40][41][42][43][44]51,57 were regarded as having a low risk of bias, the remaining studies were found to have variable degrees of risk of bias. Fourteen studies had high risk of bias 27,[34][35][36]38,45,[47][48][49][50]52,[54][55][56] with issues in randomisation and/or allocation concealment.…”

Postextubation Noninvasive Ventilation in Respiratory Distress Syndrome: A Randomized Controlled Trial

“…Similarly, Victor et al 21 reported that N-BiPAP was no more beneficial than NCPAP as a postextubation mode in preterm infants. Moreover, Lee et al 23 confirmed the previous findings and concluded that there was no significant difference in treatment failure between N-BiPAP and NCPAP as the initial management of respiratory distress in premature infants; the risk difference comparing treatment failure rate between the two groups was À4.7 percentage points (95% CI: À21.5 to 11.9). Jasani et al 24 reported similar extubation failure rates of 19.3% of NIPPV neonates compared with 28.12% of NCPAP neonates (p ¼ 0.55).…”