Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
NCT ID: NCT00977912
Last Updated: 2013-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
318 participants
INTERVENTIONAL
2009-11-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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"Milk" containing B. Lactis
"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.
Probiotic supplementation
one capsule containing probiotics per day added to milk
"Milk" containing placebo
"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.
Milk containing placebo
one capsule containing placebo per day added to milk
Interventions
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Probiotic supplementation
one capsule containing probiotics per day added to milk
Milk containing placebo
one capsule containing placebo per day added to milk
Eligibility Criteria
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Inclusion Criteria
* Tolerating enteral feeding within 48 hours
* Having obtained his/her parents or legal representative informed consent
Exclusion Criteria
* Hydrops featalis
* Congenital malformation of the gastrointestinal tract
* Congenital heart defects or other major congenital abnormalities likely to affect feeding and/or feeding tolerance
* Currently participating in another clinical trial
12 Hours
48 Hours
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Peter A. Cooper, MD
Role: PRINCIPAL_INVESTIGATOR
University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
Locations
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University of Witwatersrand & Chris Hani Baragwanath Hospital
Bertsham, , South Africa
University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
Johannesburg, , South Africa
University of Witwatersrand & Rahima Moosa Mother & Child Hospital
Johannesburg, , South Africa
Countries
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References
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Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6.
Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.
Other Identifiers
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08.09.INF
Identifier Type: -
Identifier Source: org_study_id