Trials Sponsors Conditions Drugs Pricing

Conditions

Lung Disease Hypoxemia Respiratory Acidosis

Outcome Measures

Primary Outcomes (1)

PaO2 level
at baseline, then every hour for 6 hours

Secondary Outcomes (2)

Methemoglobin level
at baseline then every hour of treatment
Alveolar-arterial oxygen gradient and ratio
after 1 hour of treatment

Study Arms (2)

1

EXPERIMENTAL

Nitric Oxide for Inhalation

Drug: nitric oxide for inhalation

2

PLACEBO COMPARATOR

oxygen

Drug: Oxygen

Interventions

nitric oxide for inhalationDrug

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

Also known as: INOmax

OxygenDrug

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

Eligibility Criteria

AgeUp to 120 Hours

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Gestational age \>34 completed weeks (\>=35)
Age \<48 hours

Sponsors & Collaborators

Mallinckrodt
Industrylead

Study Sites (1)

The University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Related Publications (1)

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. doi: 10.1371/journal.pone.0004312. Epub 2009 Feb 2.
PMID: 19183804DERIVED

MeSH Terms

Conditions

Lung DiseasesHypoxiaAcidosis, Respiratory

Interventions

Nitric OxideInhalationEndothelium-Dependent Relaxing FactorsOxygen

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory InsufficiencyRespiration DisordersAcidosis

Study Officials

Waldemar Carlo, MD
University of Alabama at Birmingham
PRINCIPAL INVESTIGATOR

Enrollment

7 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 10, 2002

First Posted

July 11, 2002

Study Start

May 2002

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations