Neurodevelopmental Outcomes and Fluconazole Prophylaxis (NDFP)
| Tracking Information | |||||
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| First Received Date ICMJE | September 11, 2009 | ||||
| Last Updated Date | January 14, 2013 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00975949 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neurodevelopmental Outcomes and Fluconazole Prophylaxis | ||||
| Official Title ICMJE | Neurodevelopmental Outcomes and Quality of Life and Fluconazole Prophylaxis | ||||
| 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. |
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| 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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Subjects were born <1000 grams, treated in our NICU, and are now 7 to 10 years of age. |
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| Condition ICMJE | Neurodevelopmental Outcomes | ||||
| Intervention ICMJE | Other: Survey
Parents of subjects were interviewed and two surveys were obtained, the Child Health Questionnaire and the Vineland-II. |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 39 | ||||
| Completion Date | June 2010 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 10 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00975949 | ||||
| Other Study ID Numbers ICMJE | 13697 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | David A Kaufman, University of Virginia | ||||
| Study Sponsor ICMJE | University of Virginia | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Virginia | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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