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Low-Dose Nitric Oxide Therapy for Persistent Pulmonary Hypertension: 1-Year Follow-up

Journal of Perinatology volume 23, pages 300–303 (2003)Cite this article

Abstract

BACKGROUND: Although inhaled nitric oxide has been shown to reduce the use of extracorporeal membrane oxygenation, there is limited data on its effect on long-term outcomes.

OBJECTIVE: The purpose of our study is to report on the 1 year outcome of neonates treated with inhaled nitric oxide compared to a group of neonates who did not receive nitric oxide.

METHODS: We have previously reported on the in-hospital outcomes of 248 neonates who were >34 weeks' gestational age and were randomized to receive low-dose inhaled nitric oxide or placebo. Extracorporeal membrane oxygenation was used in 78 (64%) neonates in the control group and in 48 (38%) neonates in the inhaled nitric oxide group (p=0.001). We now report on the outcome of neonates followed to 1 year of age.

RESULTS: Of the 248 neonates twenty-four (10%) died before 1 year of age. There was no difference in mortality between the two groups (11% in the control group and 9% in the inhaled nitric oxide group). Of the 224 surviving infants, we were able to contact the parents or guardians of 201 (90%) children. There were no intergroup differences in the numbers of patients reported as requiring medications for pulmonary disease (14% in the control group and 14% in the inhaled nitric oxide group) or the need for supplemental oxygen (1% in the control group and 0% in the inhaled nitric oxide group). The number of neonates reported to have an abnormal neurological examination or developmental delay was also similar in both groups (14% in the control group and 19% in the inhaled nitric oxide group).

CONCLUSIONS: The use of low-dose inhaled nitric oxide reduces the use of extracorporeal membrane oxygenation without increasing the incidence of adverse outcomes to 1 year of age.

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Acknowledgements

This study was funded in part by a grant from INO Therapeutics, Inc., Liberty Corner, NJ, USA. Dr. Reese Clark has acted as a consultant to INO Therapeutics, Inc. regarding submission of data to the US Food & Drug Administration (FDA). He is also the principal investigator for the grant that supports this study. Ms. Jeryl Huckaby has acted as a clinical research associate for INO Therapeutics, Inc. in monitoring this study's case report forms. None of the authors own stock or have any financial interest in INO Therapeutics, Inc.

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Authors and Affiliations

  1. Pediatrix Medical Group, Inc., Sunrise, FL, USA

    Reese H Clark MD

  2. Egleston Children's Hospital, Atlanta, GA, USA

    Jeryl L Huckaby RRT

  3. Division of Neonatology, Carolinas Medical Center, Charlotte, NC, USA

    Thomas J Kueser MD

  4. Department of Neonatology, Greenville Hospital System, Greenville, SC, USA

    Marshall W Walker MD

  5. Medical University of South Carolina, Charleston, SC, USA

    W Michael Southgate MD

  6. Arnold Palmer Hospital, Orlando, FL, USA

    Jose A Perez MD

  7. Department of Pediatrics, Emory University, Atlanta, GA, USA

    Beverly J Roy MD

  8. Division of Neonatology, Georgetown University Hospital, (m.k.), Washington, DC, USA

    Martin Keszler MD

Authors
  1. Reese H Clark MD
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  2. Jeryl L Huckaby RRT
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  3. Thomas J Kueser MD
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  4. Marshall W Walker MD
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  5. W Michael Southgate MD
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  6. Jose A Perez MD
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  7. Beverly J Roy MD
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  8. Martin Keszler MD
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For the Clinical Inhaled Nitric Oxide Research Group (CINRGI)

Appendix

Appendix

The Collaborative Inhaled Nitric Oxide Research Initiative (CINRGI) included the following institutions and investigators. Akron, OH — J. Butler, K. Wellendorf; Durham, NC — K. Auten; Phoenix, AZ — D. Hall, E. Ramthun; Atlanta, GA — J. Huckaby, L. Jain, B. Roy, I. Seabrook; Washington, DC — M. Keszler, P. Angelus; Charlotte, NC — T. Kueser, L. Brucoli; Columbia, SC — D. Marsh, A. O'Dell; New Orleans, LA — M. McGettigan, B. uinn, G. Matranga; St. Petersburg, FL — A. Napolitano, R. Williams; San Antonio, TX — M. Odom; Orlando, FL — J. Perez, J. Ramos; Chicago, IL — M. Rathi, A. Shukla, T. Gardner; Charleston, SC — M. Southgate, D. Purohit, S. Ballard, M. Nussbaum; Sioux Falls, SD — D. Stevens, R. Klinghagen; Greenville, SC — W. Walker, V. Jenkinson; Nashville, TN — W. Walsh, S. Steele, B. Canter; Lackland AFB, TX — B. Yoder, S. Woodcox.

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Clark, R., Huckaby, J., Kueser, T. et al. Low-Dose Nitric Oxide Therapy for Persistent Pulmonary Hypertension: 1-Year Follow-up. J Perinatol 23, 300–303 (2003). https://doi.org/10.1038/sj.jp.7210908

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