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Completed

NCT Number: NCT01472471

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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Key information

Conditions

Childhood Asthma Oxidative Stress

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Long Island Children's Hospital at Stony Brook

Stony Brook, New York, 11794-8111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 16, 2011
Registry last updated
Jun 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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