Nitric Oxide Administration Using an Oxygen Hood: A Pilot Trial |
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Authors: | Namasivayam Ambalavanan George T. El-Ferzli Claire Roane Robert Johnson Waldemar A. Carlo |
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Affiliation: | Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, United States of America.;Center for Research for Mothers & Children (CRMC), United States of America |
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Abstract: | BackgroundWe have shown earlier that inhaled nitric oxide (iNO) administered by oxygen hood reduces pulmonary hypertension in an animal model (J Perinatol 2002; 22:50-6). Our objective in this study was to determine feasibility of iNO by oxygen hood in neonates with elevated alveolar-arterial oxygen gradients (A-aDO2).Methods/Principal FindingsMasked randomized controlled pilot trial. Inclusion criteria were: gestation≥34 weeks, age<7 days, with post-ductal arterial line, and A-aDO2 400–600. Infants were randomized to study gas (iNO 20 ppm or equivalent O2 flow) for 1 hr which was then weaned over the next 4 hours. Primary outcome was PaO2 one hour post-randomization. Four infants each were randomized to iNO or O2 (controls). Two of the four infants given iNO had an increase in PaO2 of >100 torr, while oxygenation was unchanged in the controls. Methemoglobinemia and other adverse effects were not noted in any infant. Environmental levels of NO and NO2 were minimal (<1 ppm) at >0.3 m from the hood.ConclusionsAdministration of iNO by oxygen hood is feasible. Larger randomized controlled trials are required to measure the efficacy and determine an appropriate target population for this technique.Trial RegistrationClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00041548","term_id":"NCT00041548"}}NCT00041548 |
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