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

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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

This Tabular View shows the required WHO registration data elements as marked by ^†

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 ^†

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

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.