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

Phase 2TerminatedNCT00041548

Mallinckrodt7 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Lung Disease Hypoxemia Respiratory Acidosis

Interventions

nitric oxide for inhalationDRUG

given at 20 ppm for 1 hour then weaned off over 4 hours

OxygenDRUG

given at 20 ppm for one hour, then weaned off over four hours

Eligibility

Sex: ALLMax age: 120 Hours

Medical Language ↔ Plain English

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

Locations (1)

The University of Alabama Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

PaO2 level

Time frame: at baseline, then every hour for 6 hours

Secondary Outcomes

Methemoglobin level

Time frame: at baseline then every hour of treatment

Alveolar-arterial oxygen gradient and ratio

Time frame: after 1 hour of treatment

Data from ClinicalTrials.gov

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