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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01531179 |
Date of registration:
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04/02/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants
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Scientific title:
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Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants |
Date of first enrolment:
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February 2012 |
Target sample size:
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400 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01531179 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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Phase:
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Phase 3
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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 |
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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Necrotizing Enterocolitis
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Very Low Birth Weight Infants
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Intervention(s)
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Drug: Lactobacillus reuteri
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Drug: Placebo
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Primary Outcome(s)
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Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants
[Time Frame: up to 6 months]
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Secondary Outcome(s)
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Effect of Lactobacillus reuteri on culture proved sepsis
[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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Effect of Lactobacillus reuteri on weight gain
[Time Frame: up to 6 months]
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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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