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Updated: Jun 26, 2026

A Novel Inhalation Mask System to Deliver High Concentrations of Nitric Oxide Gas in Spontaneously Breathing Subjects
Published on: May 4, 2021
Nitric oxide administration using an oxygen hood: a pilot trial
Namasivayam Ambalavanan1, George T El-Ferzli, Claire Roane
1Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, United States of America. ambal@uab.edu
Inhaled nitric oxide (iNO) delivered via oxygen hood appears feasible for neonates with elevated alveolar-arterial oxygen gradients (A-aDO2). This pilot study suggests potential for improved oxygenation without adverse effects, warranting further investigation.
Area of Science:
- Neonatal Medicine
- Respiratory Physiology
- Pharmacology
Background:
- Previous research demonstrated inhaled nitric oxide (iNO) effectively reduces pulmonary hypertension in animal models.
- Elevated alveolar-arterial oxygen gradients (A-aDO2) in neonates indicate impaired gas exchange.
- This study aimed to assess the feasibility of administering iNO via oxygen hood in this specific neonatal population.
Purpose of the Study:
- To determine the feasibility of using an oxygen hood for inhaled nitric oxide (iNO) delivery in neonates.
- To evaluate the safety and preliminary efficacy of iNO in neonates with elevated A-aDO2.
- To establish a foundation for larger clinical trials on iNO for neonatal respiratory distress.
Main Methods:
- A masked, randomized controlled pilot trial was conducted.
- Inclusion criteria: gestation ≥34 weeks, age <7 days, post-ductal arterial line, and A-aDO2 of 400-600 mmHg.
- Infants received either iNO (20 ppm) or oxygen for 1 hour, followed by a 4-hour wean. Primary outcome: PaO2 at 1 hour.
Main Results:
- Four infants were randomized to the iNO group and four to the control (oxygen) group.
- Two of the four infants receiving iNO showed a significant increase in PaO2 (>100 torr).
- No significant changes in oxygenation were observed in the control group. No adverse effects like methemoglobinemia were noted. Environmental NO/NO2 levels remained minimal.
Conclusions:
- Inhaled nitric oxide administration via oxygen hood is feasible in neonates with elevated A-aDO2.
- The pilot study indicates a potential for improved oxygenation.
- Larger randomized controlled trials are necessary to confirm efficacy and define the optimal patient population for this intervention.
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