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Use of inhaled nitric oxide in preterm vs term/near-term neonates with pulmonary hypertension: results of the PaTTerN registry study

Journal of Perinatology volume 42, pages 14–18 (2022)Cite this article

Subjects

Abstract

Objective

To evaluate inhaled nitric oxide (iNO) in preterm (PT) vs term/near-term (TNT) neonates with hypoxic respiratory failure (HRF) and pulmonary hypertension (PH) in an observational registry (PaTTerN).

Study design

Non-inferiority study comparing PT neonates of GA ≥ 27 to <34 weeks vs TNT neonates of GA ≥ 34 to ≤40 weeks with HRF associated with PH, who received iNO for 24–96 h during the first 0–7 days after birth. Primary endpoint: Achieving ≥25% decrease in oxygenation index/surrogate oxygenation index during iNO treatment.

Results

Of 140 neonates (PT, n = 55; TNT, n = 85), the primary endpoint was achieved in 50 (90.9%) PT vs 75 (88.2%) TNT neonates (difference [95% CI]: 0.027 [−0.033, 0.087]); PT neonates achieved non-inferiority interval, and the study was stopped early based on prespecified criteria.

Conclusions

Use of iNO for improving oxygenation in PT neonates with HRF associated with PH is at least as effective as in TNT neonates.

Clinical trial registration

#NCT03132428, registered April 27, 2017

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Fig. 1: The PaTTerN study design.
Fig. 2: Mean time to ≥25% decrease in OI/SOI.
Fig. 3: Time to first occurrence of 25% decrease in OI or SOI.

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Data availability

Discussion of statistical endpoints and analysis are included in the manuscript. Summary aggregate (basic) results (including adverse events information) and the study protocol will be available on clinicaltrials.gov (NCT03132428) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

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Acknowledgements

Medical writing and editorial support, which was conducted in accordance with Good Publication Practice (GPP3) and the International Committee of Medical Journal Editors (ICMJE) guidelines, was provided by Michael D. Morren, RPh, MBA, of Peloton Advantage, LLC, an OPEN Health company, and was funded by Mallinckrodt Pharmaceuticals. The authors wish to thank the patients’ families and research coordinators for participating in the registry.

Funding

This study was funded by Mallinckrodt Pharmaceuticals.

Author information

Authors and Affiliations

  1. The Research Institute at Nationwide Children’s Hospital, Ohio State University, Columbus, OH, USA

    Leif Nelin

  2. University of Colorado School of Medicine/Children’s Hospital Colorado, Aurora, CO, USA

    John P. Kinsella

  3. Arkansas Children’s Hospital Research Institute, University of Arkansas for Medical Sciences/Arkansas Children’s Hospital, Little Rock, AR, USA

    Sherry E. Courtney

  4. Levine Children’s Hospital, Atrium Health, Charlotte, NC, USA

    Eugenia K. Pallotto

  5. Mallinckrodt Pharmaceuticals, Hampton, NJ, USA

    Eva Tarau & Jim L. Potenziano

Authors
  1. Leif Nelin
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  4. Eugenia K. Pallotto
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  5. Eva Tarau
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  6. Jim L. Potenziano
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Contributions

JPK contributed to the study design. SEC, EP, and LDN were study investigators, and enrolled patients. EP collected and assembled the data. All authors contributed to the data interpretation, paper review and revisions, and provided final approval on the submitted draft.

Corresponding author

Correspondence to Leif Nelin.

Ethics declarations

Competing interests

JPK received an investigator-initiated grant from Mallinckrodt to fund a registry for preterm newborns with pulmonary hypertension. ET is an employee of Mallinckrodt Pharmaceuticals and may hold stock or stock options in that company. JLP is a former employee of Mallinckrodt Pharmaceuticals. All other authors declare no competing interests.

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Nelin, L., Kinsella, J.P., Courtney, S.E. et al. Use of inhaled nitric oxide in preterm vs term/near-term neonates with pulmonary hypertension: results of the PaTTerN registry study. J Perinatol 42, 14–18 (2022). https://doi.org/10.1038/s41372-021-01252-x

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