Status:

COMPLETED

Neurodevelopmental Outcomes and Fluconazole Prophylaxis

Lead Sponsor:

University of Virginia

Conditions:

Neurodevelopmental Outcomes

Eligibility:

All Genders

7-10 years

Brief Summary

The purpose of this study is to compare the neurodevelopmental outcome and quality of life between the fluconazole-treated and the placebo-treated patients that were enrolled in a fluconazole prophyla...

Detailed Description

Invasive fungal infections in preterm infants is associated with significant morbidity and mortality. Mortality in infected infants \< 1000 grams is between 26-66% and neurodevelopmental impairment oc...

Eligibility Criteria

Inclusion

  • Parents or guardians and their infants who survived and were enrolled in our initial study of fluconazole prophylaxis for prevention of fungal colonization and infection in preterm infants \< 1000 grams

Exclusion

  • Persons not meeting the inclusion criteria

Key Trial Info

Start Date :

June 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2010

Estimated Enrollment :

39 Patients enrolled

Trial Details

Trial ID

NCT00975949

Start Date

June 1 2008

End Date

June 1 2010

Last Update

January 15 2013

Active Locations (1)

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1

University of Virginia Neonatal Intensive Care Unit

Charlottesville, Virginia, United States, 22908