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


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Nitric Oxide

INOmax



Clinical Trial: Inhaled Nitric Oxide in Neonates with Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation

This study is currently recruiting patients.

Sponsored by: INO Therapeutics
Information provided by: INO Therapeutics

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 Treatment or Intervention Phase
Lung Disease
Hypoxemia
Respiratory Acidosis
 Drug: INOmax (nitric oxide for inhalation)
Phase III

MedlinePlus related topics:  Metabolic Disorders;   Respiratory Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  40

Study start: May 2002;  Expected completion: November 2003

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

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

Location and Contact Information

Robert Small      908-238-6605    Robert.Small@inotherapy.com

Alabama
      The University of Alabama Birmingham, Birmingham,  Alabama,  35233,  United States; Recruiting
Waldemar Carlo, MD,  Principal Investigator

More Information

Study ID Numbers:  CARLW1
Record last reviewed:  February 2005
Last Updated:  February 7, 2005
Record first received:  July 10, 2002
ClinicalTrials.gov Identifier:  NCT00041548
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: June 1, 2005
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