Neurodevelopmental Outcomes and Fluconazole Prophylaxis (NDFP)

January 14, 2013 updated by: David A Kaufman, University of Virginia

Neurodevelopmental Outcomes and Quality of Life and Fluconazole Prophylaxis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 occurs in 57%.1-13 Between 1998-2000 we conducted a randomized placebo controlled trial of fluconazole prophylaxis in 100 infants <1000 grams at birth(IRB-HSR #9389). Invasive fungal infections occurred in none of the fluconazole-treated patients compared to 20% of the placebo group. Following this study the efficacy has been confirmed in a multicenter randomized controlled trial and 7 retrospective studies. One major issue that has remained is whether the fluconazole-treated infants have better neurodevelopmental outcomes as well as if it is safe without an increase in neurodevelopmental impairment.

Neurodevelopmental outcomes can be assessed by testing and examinations or by parental and child questionnaires. In addition, quality of life is an important context of outcomes. Recent conceptualizations of quality of life recognize the multidimensional nature of quality of life, including psychological and social functioning, consistent with the World Health Organization's definition of health as "not only the absence of disease and infirmity, but the presence of physical, mental, and social well-being." The World Health Organization subsequently emphasized the growing consensus that quality of life is a subjective experience, defined as "individuals' perceptions of their position in life in the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards, and concerns."

To address these issues, we aim to study and compare the neurodevelopmental outcome and quality of life between our fluconazole-treated and placebo-treated patients in our initial study

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Neonatal Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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 Criteria:

  • Persons not meeting the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fluconazole Group
These subjects received fluconazole in our NICU fluconazole prophylaxis study during 1998-2000
Other: Survey
Parents of subjects were interviewed and two surveys were obtained, the Child Health Questionnaire and the Vineland-II.
Placebo Group
These subjects received a placebo during our NICU fluconazole prophylaxis study during 1998-2000
Other: Survey
Parents of subjects were interviewed and two surveys were obtained, the Child Health Questionnaire and the Vineland-II.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neurodevelopmental impairment and poor quality of life
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: David Kaufman, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (Estimate)

September 14, 2009

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13697

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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