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

Sponsor:	INO Therapeutics
Information provided by:	INO Therapeutics
ClinicalTrials.gov Identifier:	NCT00041548

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	Intervention	Phase
Lung Disease Hypoxemia Respiratory Acidosis	Drug: nitric oxide for inhalation Drug: Oxygen	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy

Drug Information available for: Nitric oxide

U.S. FDA Resources

Further study details as provided by INO Therapeutics:

Primary Outcome Measures:

PaO2 level [ Time Frame: at baseline, then every hour for 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Methemoglobin level [ Time Frame: at baseline then every hour of treatment ] [ Designated as safety issue: Yes ]
Alveolar-arterial oxygen gradient and ratio [ Time Frame: after 1 hour of treatment ] [ Designated as safety issue: No ]

Enrollment:	7
Study Start Date:	May 2002
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Nitric Oxide for Inhalation	Drug: nitric oxide for inhalation given at 20 ppm for 1 hour then weaned off over 4 hours Other Name: INOmax
Placebo Comparator: 2 oxygen	Drug: Oxygen given at 20 ppm for one hour, then weaned off over four hours

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.

Eligibility

Ages Eligible for Study:	up to 120 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041548

Locations

United States, Alabama
The University of Alabama Birmingham
Birmingham, Alabama, United States, 35233

Sponsors and Collaborators

INO Therapeutics

Investigators

Principal Investigator:

Waldemar Carlo, MD

University of Alabama at Birmingham

More Information

No publications provided by INO Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ambalavanan N, El-Ferzli GT, Roane C, Johnson R, Carlo WA. Nitric oxide administration using an oxygen hood: a pilot trial. PLoS ONE. 2009;4(2):e4312. Epub 2009 Feb 2.

Responsible Party:	Robert Small, INO Therapeutics
ClinicalTrials.gov Identifier:	NCT00041548 History of Changes
Other Study ID Numbers:	CARLW1
Study First Received:	July 10, 2002
Last Updated:	June 9, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Acidosis
Acidosis, Respiratory
Lung Diseases
Anoxia
Acid-Base Imbalance
Metabolic Diseases
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Nitric Oxide
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012