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

September 11, 2009
January 14, 2013
June 2008
October 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00975949 on ClinicalTrials.gov Archive Site
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Neurodevelopmental Outcomes and Fluconazole Prophylaxis
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.

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

Observational
Time Perspective: Prospective
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Probability Sample

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

Neurodevelopmental Outcomes
Other: Survey
Parents of subjects were interviewed and two surveys were obtained, the Child Health Questionnaire and the Vineland-II.
  • Fluconazole Group
    These subjects received fluconazole in our NICU fluconazole prophylaxis study during 1998-2000
    Intervention: Other: Survey
  • Placebo Group
    These subjects received a placebo during our NICU fluconazole prophylaxis study during 1998-2000
    Intervention: Other: Survey
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
June 2010
October 2008   (final data collection date for primary outcome measure)

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
Both
7 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00975949
13697
Yes
David A Kaufman, University of Virginia
University of Virginia
Not Provided
Principal Investigator: David Kaufman, MD University of Virginia
University of Virginia
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP