Neurodevelopmental Outcomes and Fluconazole Prophylaxis

Neurodevelopmental Outcomes Clinical Trial

— NDFP  

Official title:

Neurodevelopmental Outcomes and Quality of Life and Fluconazole Prophylaxis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975949
• Other study ID #: 13697
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2009
• Last updated: January 14, 2013
• Start date: June 2008
• Est. completion date: June 2010

Study information

• Verified date: January 2013
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2010
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 10 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Neurodevelopmental Outcomes

Intervention

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

Locations

Country	Name	City	State
United States	University of Virginia Neonatal Intensive Care Unit	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes