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

• Status: Terminated
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Nitric Oxide

Criteria

Inclusion criteria:

• 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

Exclusion criteria:

• 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