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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Disease, Hypoxemia, Respiratory Acidosis

Intervention / Treatment
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* Drug: nitric oxide for inhalation
* Drug: Oxygen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 120 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Nitric Oxide for Inhalation | Drug: nitric oxide for inhalation<br>* given at 20 ppm for 1 hour then weaned off over 4 hours<br>* Other names: INOmax;|
| Placebo Comparator: 2<br>oxygen | Drug: Oxygen<br>* given at 20 ppm for one hour, then weaned off over four hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2 level |  | at baseline, then every hour for 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methemoglobin level |  | at baseline then every hour of treatment | 
| Alveolar-arterial oxygen gradient and ratio |  | after 1 hour of treatment |