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Abstract
Objective To determine leakage for two neonatal continuous positive airway pressure (CPAP) interfaces and evaluate leak-corrective manoeuvres.
Design The ToNIL (Trial of NCPAP Interface Leakage) study was a randomised, clinical, cross-over trial with data collection between August 2018 and October 2019. The primary outcome was blinded to the treating staff.
Setting One secondary, 8-bed neonatal intensive care unit (NICU) and three larger (>15 beds), academic NICU referral centres.
Patients Newborn infants with CPAP were screened (n=73), and those with stable spontaneous breathing, low oxygen requirement, postmenstrual age (PMA) over 28 weeks and no comorbidities were eligible. In total, 50 infants were included (median PMA 33 completed weeks).
Interventions Leakage was measured for both prongs and nasal mask, before and after leak-corrective manoeuvres. Interface application was performed in a randomised order by a nurse, blinded to the measured leakage.
Main outcome measures 30 s average leakage, measured in litres per minute (LPM).
Results Analyses showed a significantly lower leakage (mean difference 0.86 LPM, 95% CI 0.07 to 1.65) with prongs (median 2.01 LPM, IQR 1.00–2.80) than nasal mask (median 2.45 LPM, IQR 0.99–5.11). Leak-corrective manoeuvres reduced leakage significantly for both prongs (median 1.22 LPM, IQR 0.54–1.87) and nasal mask (median 2.35 LPM, IQR 0.76–4.75).
Conclusions Large leakages were common for both interfaces, less with prongs. Simple care manoeuvres reduced leakage for both interfaces. This is the first report of absolute leakage for nasal interfaces and should encourage further studies on leakage during CPAP treatment.
- neonatology
- resuscitation
- technology
Data availability statement
Data are available on reasonable request. Deidentified participant data and full trial protocol available from corresponding author to researchers who provide a methodologically sound proposal. Reuse of data permitted to achieve aims in the approved proposal.
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Data availability statement
Data are available on reasonable request. Deidentified participant data and full trial protocol available from corresponding author to researchers who provide a methodologically sound proposal. Reuse of data permitted to achieve aims in the approved proposal.
Footnotes
Contributors MF, TD: study design, equipment development, data collection, data and statistical analysis and manuscript writing. KG, SB, SD: study design, data collection, manuscript writing and review. BJ: study design, data interpretation, manuscript writing and review.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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