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

This study has been terminated.
Study NCT00041548.   Last updated on February 27, 2008.   Information provided by INO Therapeutics

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Descriptive Information Fields
Brief Title  Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
Official Title  Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
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.

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.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  PaO2 level [ Time Frame: at baseline, then every hour for 6 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ]
Condition  Lung Disease
Hypoxemia
Respiratory Acidosis
Intervention  Drug: nitric oxide for inhalation
Drug: Oxygen
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment  7
Start Date  May 2002
Completion Date June 2005
Eligibility 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
Gender Both
Ages up to 120 Hours
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00041548
Organization ID CARLW1
Secondary IDs ††
Study Sponsor  INO Therapeutics
Collaborators ††
Investigators 
Principal Investigator:     Waldemar Carlo, MD     University of Alabama at Birmingham    
Information Provided By INO Therapeutics
Verification Date February 2008
First Received Date  July 10, 2002
Last Updated Date February 27, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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