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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 )
Study NCT00041548   Information provided by INO Therapeutics
First Received: July 10, 2002   Last Updated: January 9, 2009   History of Changes

July 10, 2002
January 9, 2009
May 2002
June 2005   (final data collection date for primary outcome measure)
PaO2 level [ Time Frame: at baseline, then every hour for 6 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00041548 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation

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.

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.

Phase I, Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Lung Disease
  • Hypoxemia
  • Respiratory Acidosis
  • Drug: nitric oxide for inhalation
  • Drug: Oxygen
  • Experimental: Nitric Oxide for Inhalation
  • Placebo Comparator: oxygen
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
7
June 2005
June 2005   (final data collection date for primary outcome measure)

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
Both
up to 120 Hours
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00041548
Robert Small, INO Therapeutics
CARLW1
INO Therapeutics
 
Principal Investigator: Waldemar Carlo, MD University of Alabama at Birmingham
INO Therapeutics
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP