NCT00041548

Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 120 Hours
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects.

Detailed description

It is possible that administration of inhaled NO to neonates with abnormal gas exchange earlier, rather than later as a rescue therapy in a moribund state, might accelerate the transition of the circulation from the fetal to neonatal physiology and improve oxygenation. This may in turn decrease the need for mechanical ventilation, its associated morbidity and perhaps even ECMO. This study is designed as a pilot study to evaluate the physiologic efficacy (rather than effect on clinical outcomes) of NO administered by hood in improving oxygenation of neonates with elevated A-a DO2.

Conditions

• Lung Disease
• Hypoxemia
• Respiratory Acidosis

Interventions

Type	Name	Description
DRUG	nitric oxide for inhalation	given at 20 ppm for 1 hour then weaned off over 4 hours
DRUG	Oxygen	given at 20 ppm for one hour, then weaned off over four hours

Timeline

• Start date: 2002-05-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2002-07-11
• Last updated: 2016-10-19

Locations

1 site across 1 country: United States