Inhaled Nitric Oxide by Oxygen Hood in Neonates
- Conditions
- Respiratory FailureInfantPersistent Fetal Circulation
- Interventions
- Drug: inhaled Nitric Oxide
- Registration Number
- NCT00732537
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
Inhaled nitric oxide (iNO) improves oxygenation in term infants with respiratory failure. However, iNO has been primarily used in infants receiving mechanical ventilation. This study is a pilot study to determine if iNO given into an oxygen hood is effective in improving oxygenation in term and near-term infants who have poor oxygenation but who are not yet mechanically ventilated.
- Detailed Description
Inhaled nitric oxide (iNO) is currently used in the management of ventilated neonates with hypoxemic respiratory failure. We have shown that iNO administered by oxygen hood reduces pulmonary vascular resistance in hypoxia- and group B streptococcus-induced pulmonary hypertension in an animal model (J Perinatol 2002; 22:50-6). Our objective was to determine the feasibility of iNO administration by oxygen hood in neonates with respiratory failure. Methods: A masked randomized controlled trial was performed on eight infants with respiratory failure. Inclusion criteria were: gestation\>34 weeks, age\<7 days, with post-ductal arterial line, and A-aDO2 400-600 on two consecutive blood gases. Infants were randomized to study gas (iNO at 20 ppm or equivalent flow of O2) for 1 hr which was then weaned over the next 4 hours. The iNO was introduced into an oxygen hood using an INOvent (INO Therapeutics, Inc). The primary outcome was the PaO2 one hour after randomization. Environmental leakage of NO and NO2 were measured. Results: Four infants were randomized to iNO and four to O2 (controls). Two of the four infants given iNO had an increase in PaO2 of \>100 mm Hg, 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 (\<1ppm) to undetectable at \>0.3m from the hood. Conclusions: Administration 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- gestation >34 weeks at birth
- age <7 days
- post-ductal arterial line
- an A-aDO2 of 400 to 600 on two blood gases, at least 30 minutes apart.
- Infants with major malformations
- Infants with cardiac disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhaled Nitric Oxide inhaled Nitric Oxide iNO started at 20 ppm for 1 hour. The gas was then weaned hourly over the next 4 hours (20 ppm to 10 to 5 to 2.5 to 1 to off). Placebo Oxygen (>90% by hood) - standard therapy The Oxygen at high concentration (\>90%), which was standard therapy for PPHN, was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda).
- Primary Outcome Measures
Name Time Method PaO2 one hour after the first hour of study gas one hour after the first hour of study gas
- Secondary Outcome Measures
Name Time Method Alveolar-arterial oxygen gradient (A-a DO2) one hour of exposure to treatment gas oxygen saturation by pulse oximetry (SpO2) continuously through the study need for mechanical ventilation Continuously through the study duration of oxygen therapy continuously through the study Methemoglobin level in post-ductal arterial blood (MetHb) Hourly until completion of study in infant Platelet count As needed if bleeding Systemic blood pressure hourly Environmental NO and NO2 exposure Hourly
Trial Locations
- Locations (1)
Regional Neonatal ICU, University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States