Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
Overview
- Phase
- Phase 1
- Intervention
- nitric oxide for inhalation
- Conditions
- Lung Disease
- Sponsor
- Mallinckrodt
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- PaO2 level
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Nitric Oxide for Inhalation
Intervention: nitric oxide for inhalation
2
oxygen
Intervention: Oxygen
Outcomes
Primary Outcomes
PaO2 level
Time Frame: at baseline, then every hour for 6 hours
Secondary Outcomes
- Alveolar-arterial oxygen gradient and ratio(after 1 hour of treatment)
- Methemoglobin level(at baseline then every hour of treatment)