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Inhaled Nitric Oxide in the Treatment of Moderate Persistent Pulmonary Hypertension of the Newborn: A Randomized Controlled, Multicenter Trial

Journal of Perinatology volume 23, pages 98–103 (2003)Cite this article

Abstract

OBJECTIVE: Inhaled nitric oxide (iNO) improves oxygenation and reduces the need for extracorporeal membrane oxygenation in infants with severe persistent pulmonary hypertension of the newborn (PPHN). The effectiveness of iNO in the treatment of moderate PPHN has not been adequately defined. We therefore conducted a randomized, prospective multicenter study to assess whether iNO in patients with moderate PPHN would improve arterial paO2, prevent progression to severe PPHN, and improve outcomes.

METHODS: Infants ≥34 weeks gestation with moderate pulmonary hypertension (alveolar–arterial oxygen gradient (AaDO2) 500–599 Torr) were randomly assigned to continue standard medical therapy (control group) or standard medical therapy plus iNO (iNO group). For each patient in the iNO group, iNO concentration was increased in steps of 10–20 ppm every 30 minutes until there was no further improvement in arterial paO2. This concentration of iNO was then maintained while all other ventilatory support, including inspired oxygen concentration, was weaned according to a predefined protocol.

RESULTS: In all, 27 of 40 control patients (58%) compared to six of 40 infants (15%) in the iNO group failed assigned therapy and developed severe PPHN (p<0.0005). Arterial paO2 improved from 112±48 to 133±100 (p=0.132) in control infants compared to an increase from 101±29 to 208±118 (p<0.0005) in iNO-treated patients. For the first 36 hours after study, entry AaDO2 levels and ventilatory support were significantly lower in iNO-treated infants compared to control patients.

CONCLUSION: In patients with moderate PPHN, treatment with iNO improves arterial paO2, reduces the amount of ventilatory support needed, and prevents progression to severe PPHN.

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Acknowledgements

We thank Phyllis Anderson, RRT, and Kathy Sisco, RN, who helped in data collection and entry.

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Authors and Affiliations

  1. Department of Pediatrics, Saint Louis University, Cardinal Glennon Children's Hospital, St. Louis, 63104, MO, USA

    H Farouk Sadiq MD & Gregory Mantych MD

  2. Department of Pediatrics, Chicago Medical School, Lutheran General Children's Hospital, Park Ridge, IL, USA

    Raghbir S Benawra MD

  3. Department of Pediatrics, Division of Neonatology, UCLA Hospital, Los Angeles, CA, USA

    Uday P Devaskar MD

  4. Department of Pediatrics, University of Illinois, College of Medicine at Peoria, The Children's Hospital of Illinois, IL, USA

    James R Hocker MD

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  1. H Farouk Sadiq MD
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  2. Gregory Mantych MD
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  3. Raghbir S Benawra MD
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  4. Uday P Devaskar MD
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  5. James R Hocker MD
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Additional information

In addition to the authors, the following investigators and institutions participated in this study — John L. Hauver, BA, RRT, Cardinal Glennon Children's Hospital, St. Louis, MO, Al Rastogi, MD, Cook County Hospital, Vivek Ghai, MD, Illinois Masonic Medical, Chicago, IL, Marc G. Weiss, Monika Bhola, MD, Loyola Medical Center, Maywood, IL, Claudia Hart, MD, Magee Women's Hospital, Pittsburgh, PA, Minyuen Enger, MD, Michael Reese Hospital, Chicago, IL, Gary L. Dreyer, MD, St. John's Mercy Medical Center, St. Louis, MO, P. Tom Russell, The Children's Hospital of Illinois, OSF St. Francis Medical Center, Peoria, IL, Shamim Malik, MD, Diane M. Montoto, St. Francis Hospital, EOPC, Tulsa, OK, Ushanalini Vasan, MD, Rush-Presbyterian-St. Luke's Center, Chicago, IL.

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Sadiq, H., Mantych, G., Benawra, R. et al. Inhaled Nitric Oxide in the Treatment of Moderate Persistent Pulmonary Hypertension of the Newborn: A Randomized Controlled, Multicenter Trial. J Perinatol 23, 98–103 (2003). https://doi.org/10.1038/sj.jp.7210878

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