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Nitric oxide inhalations in bronchiolitis: A pilot, randomized, double-blinded, controlled trial.

Asher Tal1,2,3, David Greenberg2,3,4, Yossef Av-Gay3,5

  • 1Department of Pediatrics, Soroka University Medical Center, Beer-Sheva, Israel.

Pediatric Pulmonology
|November 28, 2017
PubMed
Summary

High-dose inhaled nitric oxide appears safe for infants with moderate bronchiolitis. While not reducing overall hospitalization, it shortened stays for some infants, showing promising efficacy signals.

Keywords:
bronchiolitisinhaled nitric oxide in bronchiolitisnitric oxiderandomized controlled trialrespiratory syncytial virus

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Area of Science:

  • Pediatric Respiratory Medicine
  • Critical Care
  • Pharmacology

Background:

  • Bronchiolitis is a common viral respiratory infection in infants.
  • Current treatments are primarily supportive, with limited pharmacological interventions.
  • High-dose nitric oxide has potential therapeutic benefits in respiratory conditions.

Purpose of the Study:

  • To evaluate the safety and tolerability of high-dose inhaled nitric oxide in infants with moderately severe bronchiolitis.
  • To assess the efficacy of this treatment as a secondary outcome.
  • To conduct a pilot, double-blinded, randomized controlled trial (phase IIa).

Main Methods:

  • Hospitalized infants (2-11 months) with acute bronchiolitis received intermittent inhalations of nitric oxide (160 ppm for 30 min) or oxygen/air (control) 5 times daily.
  • Safety monitored via oxygen saturation, methemoglobin, nitric dioxide (NO2) levels, and vital signs.
  • Efficacy assessed by length of hospitalization (LOS).

Main Results:

  • Forty-three infants were enrolled with comparable baseline characteristics.
  • No significant differences in adverse events or increased NO2/methemoglobin levels were observed.
  • Overall LOS did not differ between groups; however, a post-hoc analysis showed shorter LOS in the nitric oxide group for infants hospitalized over 24 hours (41.9 vs. 62.5 hours, P=0.014).

Conclusions:

  • Intermittent high-dose nitric oxide inhalation is safe and well-tolerated in infants with moderate bronchiolitis.
  • The treatment did not show a statistically significant difference in overall length of hospitalization.
  • Preliminary efficacy findings in a subgroup suggest potential benefits, warranting further investigation.