Clinical trial NCT00975949: Neurodevelopmental Outcomes and Fluconazole Prophylaxis
Official title: Neurodevelopmental Outcomes and Quality of Life and Fluconazole Prophylaxis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurodevelopmental Outcomes
Keywords: fluconazole prophylaxis
fungal colonization
fungal infection
preterm infants
long term outcomes
quality of life
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 39
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects were born \<1000 grams, treated in our NICU, and are now 7 to 10 years of age.

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.

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 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

Primary outcomes:
measure: Neurodevelopmental impairment and poor quality of life
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Neonatal Intensive Care Unit
state: Virginia
Study officials:
affiliation: University of Virginia
name: David Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
References: