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Neurodevelopmental Outcomes and Fluconazole Prophylaxis (NDFP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David A Kaufman, University of Virginia
ClinicalTrials.gov Identifier:
NCT00975949
First received: September 11, 2009
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Neurodevelopmental Outcomes
 Other: Survey
 Phase 3

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Neurodevelopmental Outcomes and Quality of Life and Fluconazole Prophylaxis

Resource links provided by NLM:

Drug Information available for: Fluconazole
U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: June 2008
Study Completion Date: June 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   7 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975949

Locations
United States, Virginia
University of Virginia Neonatal Intensive Care Unit
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: David Kaufman, MD University of Virginia
  More Information

No publications provided

Responsible Party: David A Kaufman, Prinicipal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT00975949     History of Changes
Other Study ID Numbers: 13697
Study First Received: September 11, 2009
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
fluconazole prophylaxis
fungal colonization
fungal infection
 preterm infants
long term outcomes
quality of life

Additional relevant MeSH terms:
Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013