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

This study has been terminated.
(slow enrollment)
Sponsor:
Information provided by:
INO Therapeutics
ClinicalTrials.gov Identifier:
NCT00041548
First received: July 10, 2002
Last updated: June 9, 2010
Last verified: June 2010
  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 1
Phase 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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, Respiratory
Lung Diseases
Acid-Base Imbalance
Acidosis
Metabolic Diseases
Respiration Disorders
Respiratory Insufficiency
Respiratory Tract Diseases
Nitric Oxide
Anti-Asthmatic Agents
Antioxidants
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Gasotransmitters
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014