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

Mallinckrodt

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Lung Disease

Respiratory Acidosis

Hypoxemia

Treatments

Drug: Oxygen

Drug: nitric oxide for inhalation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00041548

CARLW1

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

Under 120 hours old

Volunteers

No Healthy Volunteers

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