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Inhaled nitric oxide in infants >1500 g and <34 weeks gestation with severe respiratory failure

Journal of Perinatology volume 27, pages 347–352 (2007)Cite this article

Abstract

Objective:

Inhaled nitric oxide (iNO) use in infants >1500 g, but <34 weeks gestation with severe respiratory failure will reduce the incidence of death and/or bronchopulmonary dysplasia (BPD).

Study Design:

Infants born at <34 weeks gestation with a birth weight >1500 g with respiratory failure were randomly assigned to receive placebo or iNO.

Results:

Twenty-nine infants were randomized. There were no differences in baseline characteristics, but the status at randomization showed a statistically significant difference in the use of high-frequency ventilation (P=0.03). After adjustment for oxygenation index entry strata, there was no difference in death and/or BPD (adjusted relative risk (RR) 0.80, 95% confidence interval (CI) 0.43 to 1.48; P=0.50), death (adjusted RR 1.26, 95% CI 0.47 to 3.41; P=0.65) or BPD (adjusted RR 0.40, 95% CI 0.47 to 3.41; P=0.21).

Conclusions:

Although sample size limits our ability to make definitive conclusions, this small pilot trial of iNO use in premature infants >1500 g and <34 weeks with severe respiratory failure suggests that iNO does not affect the rate of BPD and/or death.

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Acknowledgements

Funded by National Institute of Child Health and Development (NICHD) and Department of Health and Human Services (DHHS) U10 HD34216, U10 HD27853, U10 HD27871, U10 HD40461, U10 HD40689, U10 HD27856, U10 HD27904, U10 HD40498, U10 HD40521, U01 HD36790, U10 HD21385, U10 HD27880, U10 HD27851, U10 HD 21373 and GCRCs: M01 RR 08084, M01 RR 06022, M01 RR 00750, M01 RR 00070, M01RR 00039, M01 RR00044. NO Therapeutics provided study gas, gas delivery systems, and site monitoring for all hospitals, as well as capitation funding for the hospitals that were not members of the NICHD Neonatal Research Network. INO Therapeutics was not involved in the study design, data analysis and interpretation, or paper preparation.

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Authors and Affiliations

  1. Division of Neonatal and Developmental Medicine, School of Medicine and Lucile Packard Children's Hospital, Stanford University, Palo Alto, CA, USA

    K P Van Meurs, S R Hintz, M B Ball & D K Stevenson

  2. Department of Pediatrics, Yale University School of Medicine, New Haven, CT, USA

    R A Ehrenkranz

  3. Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA

    J A Lemons

  4. Research Triangle Institute, Research Triangle Park, NC, USA

    W K Poole, R Perritt & A Das

  5. National Institute of Child Health and Human Development, Bethesda, MD, USA

    R D Higgins

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  1. K P Van Meurs
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  4. J A Lemons
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Correspondence to K P Van Meurs.

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Meurs, K., Hintz, S., Ehrenkranz, R. et al. Inhaled nitric oxide in infants >1500 g and <34 weeks gestation with severe respiratory failure. J Perinatol 27, 347–352 (2007). https://doi.org/10.1038/sj.jp.7211690

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