Urinary 8-isoprostane is Elevated in Acute Childhood Asthma

Completed

• Conditions: Childhood Asthma; Oxidative Stress

• Registration Number: NCT01472471
• Lead Sponsor: Stony Brook University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-11-11
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-16
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-05
• Last Update Posted: 2013-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We expect to see increased urinary 8-isoprostane in acute pediatric asthmatics	Urinary 8-isoprostane levels were measured at the end of subject recruitment

Secondary Outcome Measures

Name	Time	Method
We expect urinary 8-isoprostane levels to be higher with increased pediatric asthma severity.	This was calculated at the end of patient recruitment, after urinary 8-isoprostane levels were obtained

Trial Locations

Locations (1)

Long Island Children's Hospital at Stony Brook; 🇺🇸 Stony Brook, New York, United States