Abstract
Background
Optimal CPAP strategy to prevent CPAP failure defined as need for endotracheal intubation is unknown.
Objective
To evaluate the risk of CPAP failure in infants treated with high vs low CPAP strategy while receiving aerosolized calfactant in the AERO-02 clinical trial and AERO-03 expanded access program.
Methods
Infants born between 29 0/7 to 36 6/7 weeks were included. Comparisons were made between low and high CPAP groups (Low, 4–7 cm H2O; High, 8–10 cm H2O).
Results
CPAP failure and pneumothorax were not different between the groups. Odds of CPAP failure were not different after adjustment for baseline characteristics (OR = 0.61; 95% CI: 0.29, 1.24).
Conclusion
We found no difference in CPAP failure among infants who received aerosolized calfactant that were treated with high vs low CPAP strategy. Efficacy of high CPAP strategy with aerosolized surfactant treatment needs to be evaluated in future studies.
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Data availability
The data that support the findings of this study are available from the corresponding author, [DK], upon request.
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Acknowledgements
All AERO-02 and AERO-03 study investigators, Melissa Brown, Corey Commaroto, ONY Biotech Inc.
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Dinushan Kaluarachchi: Dr. Kaluarachchi designed the study, drafted the project proposal, obtained data, drafted and approved final manuscript as submitted. Henry A. Zapata: Dr. Zapata involved in designing of the study, drafted the project proposal, reviewed and approved final manuscript as submitted. Erick Gerday: Dr. Gerday involved in designing of the study, reviewed and approved final manuscript as submitted. Timothy Bahr: Dr. Bhar involved in designing of the study, reviewed and approved final manuscript as submitted. Michael R. Lasarev: Mr. Lasarev involved in designing of the study, did the data analysis, reviewed and approved final manuscript as submitted. Scott O. Guthrie: Dr. Guthrie involved in designing of the study, reviewed and approved final manuscript as submitted. Stephen Minton: Dr. Minton involved in designing of the study, reviewed and approved final manuscript as submitted. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
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DK and SG serve as consultants for ONY Biotech. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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Kaluarachchi, D.C., Gerday, E., Bahr, T. et al. High vs low CPAP strategy with aerosolized calfactant in preterm infants with respiratory distress syndrome. J Perinatol (2024). https://doi.org/10.1038/s41372-024-01959-7
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DOI: https://doi.org/10.1038/s41372-024-01959-7
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