Nitric Oxide |
INOmax |
Clinical Trial: Inhaled Nitric Oxide in Neonates with Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
This study is currently recruiting patients.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Lung Disease Hypoxemia Respiratory Acidosis | Drug: INOmax (nitric oxide for inhalation) | Phase III |
MedlinePlus related topics: Metabolic Disorders; Respiratory Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Expected Total Enrollment: 40
Study start: May 2002; Expected completion: November 2003
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.
Eligibility
Ages Eligible for Study: up to 120 Hours, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
Alabama
The University of Alabama Birmingham, Birmingham, Alabama, 35233, United States; Recruiting
More Information
Record last reviewed: February 2005
Last Updated: February 7, 2005
Record first received: July 10, 2002
ClinicalTrials.gov Identifier: NCT00041548
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- INOmax (Drug Digest)
- Nitric Oxide (Drug Digest)

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