Neurodevelopmental Outcomes and Fluconazole Prophylaxis

Study Overview
=================
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

Official Title
-----------------
Neurodevelopmental Outcomes and Quality of Life and Fluconazole Prophylaxis

Conditions
-----------------
Neurodevelopmental Outcomes

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fluconazole prophylaxis, fungal colonization, fungal infection, preterm infants, long term outcomes, quality of life