Urinary 8-isoprostane is Elevated in Acute Childhood Asthma
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Purpose
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.
| Condition |
|---|
|
Childhood Asthma Oxidative Stress |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Urinary 8-isoprostane is Elevated in Acute Childhood Asthma |
urine
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
acute asthmatic children
Children hospitalized with a diagnosis of acute asthma exacerbation
|
|
stable asthmatic children
Children with a history of asthma currently asymptomatic
|
Eligibility| Ages Eligible for Study: | 4 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
Inclusion Criteria:
Group 1
- Patients aged 4-18 years
- Known stable asthmatics on no medications or with no medication changes in 3 weeks prior to enrollment
- No asthma hospitalizations in past 3 months
- Parent available to consent
Group 2
- Patients aged 4-18
- Known asthmatic, admitted to Stony Brook University Hospital for status asthmaticus
- Parent available to consent
Exclusion Criteria:
- Any child with documented fever within 24 hours of study entry
- Any child with a known current history of tracheo- or bronchomalacia
- Any child with known clinical or laboratory evidence of shock (see below)
- Any child with history of documented immunodeficiency, rheumatologic disease, cystic fibrosis, or renal dysfunction (see below)
- Any child with a current or recent (less than 1 year) history of tracheostomy
- Any child with a known genetic abnormality
- Any pregnant child
- Any child with a history of autism
- Any child whose parent/caregiver is unable to give informed consent
Contacts and Locations| Contact: Daniel Sloniewsky, MD | 631-444-8211 | daniel.sloniewsky@sbumed.org |
| United States, New York | |
| Long Island Children's Hospital at Stony Brook | Recruiting |
| Stony Brook, New York, United States, 11794-8111 | |
| Contact: Daniel E Sloniewsky, MD 631-444-8211 daniel.sloniewsky@sbumed.org | |
| Principal Investigator: | Daniel E Sloniewsky, MD | Long Island Children's Hospital at Stony Brook |
More Information
No publications provided
| Responsible Party: | Stony Brook University |
| ClinicalTrials.gov Identifier: | NCT01472471 History of Changes |
| Other Study ID Numbers: | 171086-4 |
| Study First Received: | November 11, 2011 |
| Last Updated: | November 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Stony Brook University:
|
Childhood Asthma Oxidative stress Urinary 8-isoprostane |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases 8-epi-prostaglandin F2alpha Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013