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Response to aerosolized calfactant in infants with respiratory distress syndrome; a post-hoc analysis of AERO-02 trial

Journal of Perinatology volume 43, pages 998–1003 (2023)Cite this article

Subjects

Abstract

Background

The aerosolized calfactant decreased the need for intubation in neonates with respiratory distress syndrome (AERO-02 trial).

Objective

To determine the oxygenation response to aerosolized calfactant among infants born 28 0/7–36 6/7 weeks with RDS in the AERO-02 trial.

Methods

Trends in hourly fraction of oxygen (FiO2), mean airway pressure (MAP) and respiratory severity score (RSS) were compared between the aerosolized calfactant (AC) and usual care (UC) groups from time of randomization for 72 h.

Results

A total of 353 subjects were included in the study. FiO2, MAP, and RSS were lower in the UC group. FiO2 decrease was seen after the first aerosolized calfactant dose.

Conclusion

FiO2, MAP, and RSS were lower in the UC group. This is likely due to early and higher rate of liquid surfactant administration in the UC group. Decrease in FiO2 was noted in the AC group after the first aerosolization.

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Fig. 1
Fig. 2: Time to first liquid surfactant instillation.
Fig. 3: Response to Aerosolized Calfactant.
Fig. 4: FiO2 trends following aerosolized calfactant treatment.

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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 study investigators, Melissa Brown, Corey Commaroto, ONY Biotech Inc.

Author information

Authors and Affiliations

  1. Department of Pediatrics, Division of Neonatology, University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI, USA

    Dinushan C. Kaluarachchi & Henry A. Zapata

  2. Department of Respiratory Therapy, UnityPoint Health Meriter Hospital, Madison, WI, USA

    Heather L. Becker

  3. Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI, USA

    Michael R. Lasarev

  4. Department of Pediatrics, Division of Neonatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA

    Prem Fort

  5. Johns Hopkins All Children’s Maternal Fetal and Neonatal Institute, Johns Hopkins All Children’s Hospital, St. Petersburg, FL, USA

    Prem Fort

  6. Department of Pediatrics, Division of Neonatology, Vanderbilt University School of Medicine, Nashville, TN, USA

    Scott O. Guthrie

Authors
  1. Dinushan C. Kaluarachchi
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  5. Prem Fort
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  6. Scott O. Guthrie
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Contributions

DK: designed the study, drafted the project proposal, obtained data, drafted and approved final manuscript as submitted. HAZ: involved in designing of the study, drafted the project proposal, reviewed and approved final manuscript as submitted. HLB: involved in designing of the study, drafted the project proposal, reviewed and approved final manuscript as submitted. MRL: involved in designing of the study, did the data analysis, reviewed and approved final manuscript as submitted. PF: involved in designing of the study, reviewed and approved final manuscript as submitted. SOG: 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.

Corresponding author

Correspondence to Dinushan C. Kaluarachchi.

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Competing interests

PF and SG have worked for and received payments from ONY Biotech in the past. 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., Zapata, H.A., Becker, H.L. et al. Response to aerosolized calfactant in infants with respiratory distress syndrome; a post-hoc analysis of AERO-02 trial. J Perinatol 43, 998–1003 (2023). https://doi.org/10.1038/s41372-023-01717-1

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  • DOI: https://doi.org/10.1038/s41372-023-01717-1

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