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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01531192 |
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Date of registration:
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04/02/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
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Scientific title:
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Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey |
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Date of first enrolment:
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June 2012 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01531192 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Mehmet Yekta Oncel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Neonatology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Very low birth weight infants < 1500 gr
- Gestational age < 32 weeks
Exclusion Criteria:
- Genetic anomalies
- Short bowel syndrome
- Not willing to participate
- Allergy to Lactobacillus reuteri components
Age minimum:
N/A
Age maximum:
6 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Very Low Birth Weight Infants
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Intervention(s)
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Dietary Supplement: Lactobacillus reuteri
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Drug: Nystatin
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Primary Outcome(s)
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Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants
[Time Frame: up to 6 months]
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Secondary Outcome(s)
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Effect of Lactobacillus reuteri on sepsis
[Time Frame: up to 6 months]
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Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants
[Time Frame: up to 6 months]
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Effect of Lactobacillus reuteri on feeding intolerance
[Time Frame: up to 6 months]
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Effect of Lactobacillus reuteri on length of hospital stay
[Time Frame: up to 6 months]
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Secondary ID(s)
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ZTB630301
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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