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Nasal masks or binasal prongs for delivering continuous positive airway pressure in preterm neonates—a randomised trial

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Abstract

The objective of this study was to compare the efficacy and safety of continuous positive airway pressure (CPAP) delivered using nasal masks with binasal prongs. We randomly allocated 72 neonates between 26 and 32 weeks gestation to receive bubble CPAP by either nasal mask (n = 37) or short binasal prongs (n = 35). Primary outcome was mean FiO2 requirement at 6, 12 and 24 h of CPAP initiation and the area under curve (AUC) of FiO2 against time during the first 24 h (FiO2 AUC0–24). Secondary outcomes were the incidence of CPAP failure and nasal trauma. FiO2 requirement at 6, 12 and 24 h (mean (SD); 25 (5.8) vs. 27.9 (8); 23.8 (4.5) vs. 25.4 (6.8) and 22.6 (6.8) vs. 22.7 (3.3)) as well as FiO2 AUC0–24 (584.0 (117.8) vs. 610.6 (123.6)) were similar between the groups. There was no difference in the incidence of CPAP failure (14 vs. 20%; relative risk 0.67; 95% confidence interval 0.24–1.93). Incidence of severe nasal trauma was lower with the use of nasal masks (0 vs. 31%; p < .001).

Conclusions: Nasal masks appear to be as efficacious as binasal prongs in providing CPAP. Masks are associated with lower risk of severe nasal trauma. Trial registration: CTRI2012/08/002868

What is Known?

Binasal prongs are better than single nasal and nasopharyngeal prongs for delivering continuous positive airway pressure (CPAP) in preventing need for re-intubation.

It is unclear if they are superior to newer generation nasal masks in preterm neonates requiring CPAP.

What is New?

Oxygen requirement during the first 24 h of CPAP delivery is comparable with use of nasal masks and binasal prongs.

Use of nasal masks is, however, associated with significantly lower risk of severe grades of nasal injury.

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Abbreviations

BPD:

Bronchopulmonary dysplasia

CI:

Confidence intervals

CPAP:

Continuous positive airway pressure

FiO2 :

Fractional inspired oxygen concentration

IFD:

Infant flow driver

NNT:

Number needed to treat

OR:

Odds ratio

RCT:

Randomised controlled trial

RR:

Relative risk

RDS:

Respiratory distress syndrome

RD:

Risk difference

TTNB:

Transient tachypnoea of newborn

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Authors’ Contributions

Aparna Chandrasekaran designed the study protocol, recruited the participants, drafted the initial manuscript and modified it based on critical inputs of other authors; Anu Thukral supervised data collection, assessed the secondary outcome of nasal trauma and revised the manuscript; M Jeeva Sankar and Ramesh Agarwal helped in designing the study, supervised data collection, analysed the results and critically reviewed the final manuscript; Vinod K Paul and Ashok K Deorari conceptualised the study design and critically reviewed the manuscript; all authors approved the final manuscript.

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Correspondence to Ashok K Deorari.

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Conflicts of interest

The authors declare that they have no conflicts of interest.

Statement of human rights

All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Funding source

No funding was secured for this study.

Clinical trial registration name and number

Clinical Trial Registry - India (CTRI number 2012/08/002868)

Additional information

Communicated by Patrick Van Reempts

Revisions received: 11 November 2016; 27 December 2016; 03 January 2017

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Chandrasekaran, A., Thukral, A., Jeeva Sankar, M. et al. Nasal masks or binasal prongs for delivering continuous positive airway pressure in preterm neonates—a randomised trial. Eur J Pediatr 176, 379–386 (2017). https://doi.org/10.1007/s00431-017-2851-x

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  • DOI: https://doi.org/10.1007/s00431-017-2851-x

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