Urinary 8-isoprostane is Elevated in Acute Childhood Asthma

NCT ID: NCT01472471

Last Updated: 2013-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-02-29

Brief Summary

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Oxidative stress is seen in children with asthma, but is hard to measure. The investigators exploring the utility of using a commercially available assay to measure oxidative stress in the urine in asthmatics. Additionally, the investigators will attempt to prove that oxidative stress is higher in children with acute asthma compared to those with stable asthma and that this stress is also higher in children with more severe clinical asthma exacerbations compared to less severe ones.

Detailed Description

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Conditions

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Childhood Asthma Oxidative Stress

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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acute asthmatic children

Children hospitalized with a diagnosis of acute asthma exacerbation

No interventions assigned to this group

stable asthmatic children

Children with a history of asthma currently asymptomatic

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Group 1

1. Patients aged 4-18 years
2. Known stable asthmatics on no medications or with no medication changes in 3 weeks prior to enrollment
3. No asthma hospitalizations in past 3 months
4. Parent available to consent

Group 2

1. Patients aged 4-18
2. Known asthmatic, admitted to Stony Brook University Hospital for status asthmaticus
3. Parent available to consent

Exclusion Criteria

1. Any child with documented fever within 24 hours of study entry
2. Any child with a known current history of tracheo- or bronchomalacia
3. Any child with known clinical or laboratory evidence of shock (see below)
4. Any child with history of documented immunodeficiency, rheumatologic disease, cystic fibrosis, or renal dysfunction (see below)
5. Any child with a current or recent (less than 1 year) history of tracheostomy
6. Any child with a known genetic abnormality
7. Any pregnant child
8. Any child with a history of autism
9. Any child whose parent/caregiver is unable to give informed consent
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel E Sloniewsky, MD

Role: PRINCIPAL_INVESTIGATOR

Long Island Children's Hospital at Stony Brook

Locations

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Long Island Children's Hospital at Stony Brook

Stony Brook, New York, United States

Site Status

Countries

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United States

Other Identifiers

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171086-4

Identifier Type: -

Identifier Source: org_study_id

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