- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00975949
Neurodevelopmental Outcomes and Fluconazole Prophylaxis (NDFP)
Neurodevelopmental Outcomes and Quality of Life and Fluconazole Prophylaxis
Studieöversikt
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22908
- University of Virginia Neonatal Intensive Care Unit
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Fluconazole Group
These subjects received fluconazole in our NICU fluconazole prophylaxis study during 1998-2000
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Parents of subjects were interviewed and two surveys were obtained, the Child Health Questionnaire and the Vineland-II.
|
Placebo Group
These subjects received a placebo during our NICU fluconazole prophylaxis study during 1998-2000
|
Parents of subjects were interviewed and two surveys were obtained, the Child Health Questionnaire and the Vineland-II.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Neurodevelopmental impairment and poor quality of life
Tidsram: 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
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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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: David Kaufman, MD, University of Virginia
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 13697
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