NCT00975949

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 prophylaxis study that occurred in the investigators' neonatal intensive care unit (NICU) between 1998-2000.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

4 months

First QC Date

September 11, 2009

Last Update Submit

January 14, 2013

Conditions

Neurodevelopmental Outcomes

Keywords

fluconazole prophylaxisfungal colonizationfungal infectionpreterm infantslong term outcomesquality of life

Outcome Measures

Primary Outcomes (1)

  • Neurodevelopmental impairment and poor quality of life

    7 to 10 years after participation in the initial study of fluconazole prophylaxis for prevention of fungal colonization and infection in preterm infants <1000 grams

Study Arms (2)

Fluconazole Group

These subjects received fluconazole in our NICU fluconazole prophylaxis study during 1998-2000

Other: Survey

Placebo Group

These subjects received a placebo during our NICU fluconazole prophylaxis study during 1998-2000

Other: Survey

Interventions

SurveyOTHER

Parents of subjects were interviewed and two surveys were obtained, the Child Health Questionnaire and the Vineland-II.

Fluconazole GroupPlacebo Group

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Subjects were born \<1000 grams, treated in our NICU, and are now 7 to 10 years of age.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Neonatal Intensive Care Unit

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Mycoses

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • David Kaufman, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

June 1, 2008

Primary Completion

October 1, 2008

Study Completion

June 1, 2010

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

US(1)