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Randomized controlled trial of early compared with delayed use of inhaled nitric oxide in newborns with a moderate respiratory failure and pulmonary hypertension

Journal of Perinatology volume 30, pages 420–424 (2010)Cite this article

Abstract

Objective:

To evaluate whether early treatment with inhaled nitric oxide (iNO) will prevent newborns with moderate respiratory failure from developing severe hypoxemic respiratory failure (oxygenation index (OI)⩾40).

Study Design:

A total of 56 newborns with moderate respiratory failure (OI between 10 and 30) were randomized before 48 h after birth to early treatment with 20 p.p.m. of iNO (Early iNO group, n=28) or conventional mechanical ventilation with FiO2 1.0 (Control group, n=28). Infants received iNO and/or high-frequency oscillatory ventilation (HFOV) if they developed an OI>40.

Result:

7 of 28 early iNO patients (25%) compared to 17 of 28 control patients (61%) developed an OI>40 (P<0.05). In the Early iNO group mean OI significantly decreased from 22 (baseline) to 19 at 4 h (P<0.05) and remained lower over time: 19 (12 h), 18 (24 h) and 16 at 48 h. In contrast, OI increased in the Control group and remained significantly higher than the Early iNO group during the first 48 h of study: 22 (baseline), 29, 35, 32 and 23 at 4, 12, 24 and 48 h, respectively (P<0.01). Of 17, 6 control patients who developed an OI>40 were successfully treated with iNO. Nine of the remaining eleven control patients and six of seven Early iNO patients who had an OI>40 despite use of iNO responded with the addition of HFOV. One patient of the Early iNO group and two of the Control group died. Median (range) duration of oxygen therapy was significantly shorter in the Early iNO group: 11.5 (5 to 90) days compared to 18 (6 to 142) days of the Control group (P<0.03).

Conclusion:

Early use of iNO in newborns with moderate respiratory failure improves oxygenation and decreases the probability of developing severe hypoxemic respiratory failure.

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Acknowledgements

We thank Alessandra Gederlini for her help with the statistical analyses. We also thank Margarita Bidegain and Ronald Goldberg for their critical review of the paper.

This study was funded in part by project DIPUC 96/01E, Pontificia Universidad Católica de Chile and AGA Chile SA.

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Authors and Affiliations

  1. Division of Neonatology, Hospital Clínico Universidad Católica, Santiago, Chile

    A González, J Fabres, M Avaca & J Kattan

  2. Newborn ICU, Hospital Dr Sótero del Río, Santiago, Chile

    I D'Apremont & C Gandolfi

  3. Division of Pediatric Cardiology, Hospital Clínico Universidad Católica, Santiago, Chile

    G Urcelay

  4. Departamento de Pediatría, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile

    A González, J Fabres, I D'Apremont, G Urcelay & J Kattan

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  1. A González
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Correspondence to A González.

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González, A., Fabres, J., D'Apremont, I. et al. Randomized controlled trial of early compared with delayed use of inhaled nitric oxide in newborns with a moderate respiratory failure and pulmonary hypertension. J Perinatol 30, 420–424 (2010). https://doi.org/10.1038/jp.2009.171

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