Clinical Trial: Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
Brief 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 Summary:
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.
Sponsor: Mallinckrodt
Current Primary Outcome: PaO2 level [ Time Frame: at baseline, then every hour for 6 hours ]
Original Primary Outcome:
Current Secondary Outcome:
- Methemoglobin level [ Time Frame: at baseline then every hour of treatment ]
- Alveolar-arterial oxygen gradient and ratio [ Time Frame: after 1 hour of treatment ]
Original Secondary Outcome:
Information By: Mallinckrodt
Dates:
Date Received: July 10, 2002
Date Started: May 2002
Date Completion:
Last Updated: October 18, 2016
Last Verified: October 2016
