Inhaled Nitric Oxide by Oxygen Hood in Neonates

PHASE4CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

March 31, 1999

Primary Completion Date

June 30, 2005

Study Completion Date

June 30, 2005

Conditions
Respiratory FailureInfantPersistent Fetal Circulation
Interventions
DRUG

inhaled Nitric Oxide

"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."

DRUG

Oxygen (>90% by hood) - standard therapy

"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."

Trial Locations (1)

35233

Regional Neonatal ICU, University of Alabama at Birmingham, Birmingham

All Listed Sponsors
lead

University of Alabama at Birmingham

OTHER