Hypoxemia, Lung Disease, Respiratory Acidosis
Conditions
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.
Interventions
given at 20 ppm for 1 hour then weaned off over 4 hours
DRUGOxygen
given at 20 ppm for one hour, then weaned off over four hours
Sponsors
Mallinckrodt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 120 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PaO2 level | at baseline, then every hour for 6 hours |
Secondary
| Measure | Time frame |
|---|---|
| Methemoglobin level | at baseline then every hour of treatment |
| Alveolar-arterial oxygen gradient and ratio | after 1 hour of treatment |
Countries
United States
Outcome results
None listed