Expired Study
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Birmingham, Alabama 35233


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.


Study summary:

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.


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


Study is Available At:


Original ID:

CARLW1


NCT ID:

NCT00041548


Secondary ID:


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

120 Hours


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mallinckrodt


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

slow enrollment


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

7


Enrollment Type:

Actual


Overall Contact Information

Official Name:Waldemar Carlo, MD
Principal Investigator
University of Alabama at Birmingham

Study Dates

Start Date:May 2002
Completion Date:June 2005
Completion Type:Actual
Primary Completion Date:June 2005
Primary Completion Type:Actual
Verification Date:October 2016
Last Changed Date:October 18, 2016
First Received Date:July 10, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:PaO2 level
Time Frame:at baseline, then every hour for 6 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Methemoglobin level
Time Frame:at baseline then every hour of treatment
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Alveolar-arterial oxygen gradient and ratio
Time Frame:after 1 hour of treatment
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:nitric oxide for inhalation
Description:given at 20 ppm for 1 hour then weaned off over 4 hours
Arm Name:1
Other Name:INOmax
Intervention Type:Drug
Name:Oxygen
Description:given at 20 ppm for one hour, then weaned off over four hours
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Nitric Oxide for Inhalation
Study Arm Type:Placebo Comparator
Arm Name:2
Description:oxygen

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Mallinckrodt

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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