A Phase 4 interventional study of inhaled Nitric Oxide and Oxygen (>90% by hood) - standard therapy in Respiratory Failure, Infant and Persistent Fetal Circulation, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 1 Hour to 1 Week. Per ClinicalTrials.gov, last updated 2008-08-12.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment
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.
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.
1,675 studies on the registry are indexed under Respiratory Insufficiency; 300 are open to participants now.
This study's enrollment of 8 is below the median of 55 across 1,056 interventional studies indexed under Respiratory Insufficiency.
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Of its 160 completed or terminated interventional studies of FDA-regulated products, 128 (80%) have results posted.
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Exclusion Criteria:
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).
Drug: inhaled Nitric Oxide
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).
Drug: Oxygen (>90% by hood) - standard therapy
iNO started at 20 ppm for 1 hour, then weaned hourly over the next 4 hours (20 ppm to 10 to 5 to 2.5 to 1 to off). If \>5% drop in oxygen saturation was observed during weaning, study gas was increased to the previous concentration and weaning done 2 hourly. If \> 5% drop in oxygen saturation or \>5% Methemoglobin was observed during initial administration, the study gas would be weaned over 30 minutes and the infant would exit. The iNO was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda). The INOvent ® was connected to the oxyhood by placing the injector module inline on the dry side of the humidifier chamber. Monitoring of O2, NO2, NO was done by placing the end of the sample line inside the oxyhood. A "Masking Shield" covered the Display/Control Panel and Cylinder Gauges, in order to maintain masking of the intervention. Only the respiratory therapist and research coordinator was aware of the allocation assignment.
Also known as: iNO, Nitric Oxide
Oxygen (\>90% by hood, standard therapy for PPHN prior to intubation) was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda). The INOvent ® was connected to the oxyhood by placing the injector module inline on the dry side of the humidifier chamber. If the baby was randomized to the control group and did not receive NO, the INOmax® cylinder was opened and used only to pressurize the system, which prevented the "Low NO Pressure" alarm. A "Masking Shield" covered the Display/Control Panel and Cylinder Gauges, in order to maintain masking of the intervention. Only the respiratory therapist and research coordinator was aware of the allocation assignment.
Also known as: Oxygen, Head box
PaO2 one hour after the first hour of study gas
Time frame: one hour after the first hour of study gas
Alveolar-arterial oxygen gradient (A-a DO2)
Time frame: one hour of exposure to treatment gas
oxygen saturation by pulse oximetry (SpO2)
Time frame: continuously through the study
need for mechanical ventilation
Time frame: Continuously through the study
duration of oxygen therapy
Time frame: continuously through the study
Methemoglobin level in post-ductal arterial blood (MetHb)
Time frame: Hourly until completion of study in infant
Platelet count
Time frame: As needed if bleeding
Systemic blood pressure
Time frame: hourly
Environmental NO and NO2 exposure
Time frame: Hourly
This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nitric Oxide
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