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

Stopped early · Phase 1/Phase 2

Conditions studied: Lung Disease, Hypoxemia, Respiratory Acidosis

In brief

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.

Key facts

Study ID

NCT00041548

Run by

Mallinckrodt

People needed

7

Starts

2002-05-01

Expected to finish

2005-06-01

Last updated by the study team

2016-10-19

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age >34 completed weeks (>=35)
• Age <48 hours
• A-a DO2 400 to 600, on two post-ductal arterial blood gases one hour apart, while on 100% O2 by oxygen hood
• Post-ductal arterial access
• Admitted to The University of Alabama Birmingham Regional NICU

You may not qualify if…

• Cardiac disease (structural disease with right to left or mixing lesions), not including patent ductus arteriosus (PDA) or patent foramen ovale (PFO)
• Rapid deterioration requiring mechanical ventilation before entry into the study
• Major malformations
• Major neurologic or metabolic disorder or other illness leading to hypoventilation and hypercarbia

Where it is running

• The University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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