Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
- Conditions
- Respiratory AcidosisLung DiseaseHypoxemia
- Interventions
- Drug: nitric oxide for inhalation
- Registration Number
- NCT00041548
- Lead Sponsor
- Mallinckrodt
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 nitric oxide for inhalation Nitric Oxide for Inhalation 2 Oxygen oxygen
- Primary Outcome Measures
Name Time Method PaO2 level at baseline, then every hour for 6 hours
- Secondary Outcome Measures
Name Time Method Methemoglobin level at baseline then every hour of treatment Alveolar-arterial oxygen gradient and ratio after 1 hour of treatment
Trial Locations
- Locations (1)
The University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States