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

NCT00041548 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2016-10-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

nitric oxide for inhalation

given at 20 ppm for 1 hour then weaned off over 4 hours

DRUG

Oxygen

given at 20 ppm for one hour, then weaned off over four hours

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Waldemar Carlo, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
120 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2005-06-30
Completion
2005-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00041548 on ClinicalTrials.gov