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RAM cannula versus short binasal prongs for nasal continuous positive airway pressure delivery in preterm infants: a randomized, noninferiority trial from low-middle-income country

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Abstract

To determine if RAM cannula is non-inferior to short binasal prongs (SBP) in providing nasal continuous positive airway pressure (CPAP) in preterm infants with respiratory distress syndrome (RDS). In this randomized, open-label, noninferiority trial from a low-middle-income country, we enrolled 254 preterm infants (28–34 weeks gestational age) with RDS who needed CPAP as primary respiratory support. The eligible infants were randomized to either RAM cannula or SBP interface groups. The primary outcome was CPAP failure (defined as the need for intubation or non-invasive positive pressure ventilation) within 72 h of randomization. The noninferiority margin was defined as a 10% or less absolute difference in CPAP failure rates. The secondary outcomes included nasal trauma and adverse events. We analyzed by per-protocol (primary) and intention to treat. CPAP failure has been seen in 25 infants (19.7%) in the RAM cannula group versus 22 (17.3%) in the SBP group (RD −2.36%; 95% CI −11.9 to 7.2 [beyond inferiority margin]; p = 0.6). Moderate and severe nasal trauma was less in RAM cannula (2.4 vs. 8.7%; RR 0.27; 95% CI 0.08–0.95; p 0.028). Duration of CPAP was also significantly shorter in the RAM cannula group (MD −12.4 h; 95% CI −20.34 to −4.46, p 0.017). There were no differences in other adverse events.

Conclusions: RAM cannula was not non-inferior to SBP in providing CPAP to preterm infants with respiratory distress syndrome.

Trial registration: Registered at Clinical Trial Registry of India (CTRI/2020/03/024097).

What is Known:

• RAM cannula is used for providing supplemental oxygen therapy. There is conflicting evidence on its efficacy in delivering CPAP support in preterm infants.

What is New:

• RAM cannula was not non-inferior to SBP in providing CPAP to preterm infants with respiratory distress syndrome.

• RAM cannula causes less nasal trauma than short binasal prongs.

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Availability of data and material

The data is available with the corresponding author. Deidentified data can be provided on reasonable request.

Code availability

Custom coded data available on request.

Abbreviations

CI:

Confidence interval

CO2:

Carbon dioxide

CPAP:

Continuous positive airway pressure

FiO2:

Fraction of inspired oxygen

InSurE:

Intubate surfactant extubate

NICU:

Neonatal intensive care unit

NIPPV:

Non-invasive positive pressure ventilation

PEEP:

Peak end expiratory pressure

PPV:

Positive pressure ventilation

RCT:

Randomized controlled trial

RD:

Risk difference

RDS:

Respiratory distress syndrome

RR:

Risk ratio

SBP:

Short binasal prongs

SD:

Standard deviation

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Authors and Affiliations

  1. Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, 110029, India

    S. K. Samim, Pradeep Kumar Debata, Anita Yadav, Pratima Anand & Mehak Garg

  2. Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India

    Jogender Kumar

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Contributions

SKS: conceived idea, recruited participants, and critically reviewed the manuscript. PD and AY: conceived idea, supervised patient recruitment and data collection, participated in manuscript writing and revisions. JK: data analysis, participated in manuscript writing and revisions. PA and MG: data collection, critically reviewed and revised the manuscript. All the authors approved the final version of the manuscript and shall be accountable for all aspects of the manuscript.

Corresponding author

Correspondence to Pradeep Kumar Debata.

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Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki. The Institutional Ethics Committee of Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, approved the study protocol.

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All participants were recruited after taking written informed consent.

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All authors consented to publication.

Conflict of interest

The authors declare no competing interests.

Additional information

Communicated by Daniele De Luca

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Samim, S.K., Debata, P.K., Yadav, A. et al. RAM cannula versus short binasal prongs for nasal continuous positive airway pressure delivery in preterm infants: a randomized, noninferiority trial from low-middle-income country. Eur J Pediatr 181, 4111–4119 (2022). https://doi.org/10.1007/s00431-022-04620-7

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