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Urinary 8-isoprostane is Elevated in Acute Childhood Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stony Brook University
ClinicalTrials.gov Identifier:
NCT01472471
First received: November 11, 2011
Last updated: June 5, 2013
Last verified: June 2013

November 11, 2011
June 5, 2013
November 2010
February 2012   (final data collection date for primary outcome measure)
We expect to see increased urinary 8-isoprostane in acute pediatric asthmatics [ Time Frame: Urinary 8-isoprostane levels were measured at the end of subject recruitment ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01472471 on ClinicalTrials.gov Archive Site
We expect urinary 8-isoprostane levels to be higher with increased pediatric asthma severity. [ Time Frame: This was calculated at the end of patient recruitment, after urinary 8-isoprostane levels were obtained ] [ Designated as safety issue: No ]
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Urinary 8-isoprostane is Elevated in Acute Childhood Asthma
Urinary 8-isoprostane is Elevated in Acute Childhood Asthma

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.

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Observational
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

urine

Non-Probability Sample

Group 1:

25 subjects will be recruited from among the children seen at the Stony Brook University Pediatric Pulmonary and Allergy Clinic.

Group 2 25 subjects will be recruited from among the children admitted to Stony Brook University Hospital with a diagnosis of acute asthma exacerbation or reactive airway disease from Monday at 12 AM to Friday at 5 PM.

  • Childhood Asthma
  • Oxidative Stress
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  • acute asthmatic children
    Children hospitalized with a diagnosis of acute asthma exacerbation
  • stable asthmatic children
    Children with a history of asthma currently asymptomatic
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
4 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01472471
171086-4
No
Stony Brook University
Stony Brook University
Not Provided
Principal Investigator: Daniel E Sloniewsky, MD Long Island Children's Hospital at Stony Brook
Stony Brook University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP