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

NCT00041548 | Terminated Phase 1 DMC

• 1 other identifier: CARLW1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Disease; Hypoxemia; Respiratory Acidosis

Outcome Measures

Primary Outcomes (1)

• PaO2 level

  at baseline, then every hour for 6 hours

Secondary Outcomes (2)

• Methemoglobin level

  at baseline then every hour of treatment

• Alveolar-arterial oxygen gradient and ratio

  after 1 hour of treatment

Study Arms (2)

1

EXPERIMENTAL

Nitric Oxide for Inhalation

Drug: nitric oxide for inhalation

2

PLACEBO COMPARATOR

oxygen

Drug: Oxygen

Interventions

nitric oxide for inhalation DRUG

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

Also known as: INOmax

1

Oxygen DRUG

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

2

Eligibility Criteria

• Age: Up to 120 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (1)

The University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• 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. doi: 10.1371/journal.pone.0004312. Epub 2009 Feb 2.

  PMID: 19183804 DERIVED

MeSH Terms

Conditions

Lung Diseases; Hypoxia; Acidosis, Respiratory

Interventions

Nitric Oxide; Inhalation; Endothelium-Dependent Relaxing Factors; Oxygen

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Vasodilator Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Chalcogens; Elements; Gases

Study Officials

• Waldemar Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2002
• First Posted: July 11, 2002
• Study Start: May 1, 2002
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

US (1)