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Status:

COMPLETED

Biomarkers of Injury and Destruction in the Cystic Fibrosis Lung

Lead Sponsor:

University of Minnesota

Collaborating Sponsors:

National Institutes of Health (NIH)

Minnesota Medical Foundation

Conditions:

Cystic Fibrosis

Eligibility:

All Genders

6+ years

Brief Summary

Cystic fibrosis (CF) is the most common autosomal recessive genetic disease in Caucasians. It results in lung disease that affects quality of life and causes early death. Lung damage from CF starts in...

Detailed Description

This is a prospective, observational cohort study of two CF populations (and appropriate control populations): Infants with CF Diagnosed by Newborn Screen: The purpose of this prospective cohort stud...

Eligibility Criteria

Inclusion

  • Infant Study Inclusion Criteria
  • Age \< 6 months
  • Cystic Fibrosis Diagnosed by Newborn Screen
  • Exclusion:
  • Age over 6months
  • Child Study Inclusion Criteria
  • FEV1 \< 35% predicted A
  • Use of IV antibiotics for a pulmonary exacerbation or respiratory symptoms 12 months prior to enrollment.
  • Hospitalization for a pulmonary exacerbation 12 months prior to enrollment.
  • Use of oral antibiotic for respiratory symptoms 28 days prior to enrollment.
  • Any changes in medical regimen for treatment of CF (e.g. no addition of or elimination of therapies such as hypertonic saline, inhaled corticosteroids or mucolytic therapy) within 28 days of enrollment visit.
  • Exclusion Criteria:
  • FEV1 \< 35% predicted A
  • Use of IV antibiotics for a pulmonary exacerbation or respiratory symptoms 12 months prior to enrollment.
  • Hospitalization for a pulmonary exacerbation 12 months prior to enrollment.
  • Use of oral antibiotic for respiratory symptoms 28 days prior to enrollment.
  • Any changes in medical regimen for treatment of CF (e.g. no addition of or elimination of therapies such as hypertonic saline, inhaled corticosteroids or mucolytic therapy) within 28 days of enrollment visit.

Exclusion

    Key Trial Info

    Start Date :

    December 1 2012

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2017

    Estimated Enrollment :

    150 Patients enrolled

    Trial Details

    Trial ID

    NCT01805713

    Start Date

    December 1 2012

    End Date

    December 1 2017

    Last Update

    January 12 2018

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    University of Minnesota

    Minneapolis, Minnesota, United States, 55455