Status:
TERMINATED
Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Necrotizing Enterocolitis
Eligibility:
All Genders
12-48 years
Phase:
NA
Brief Summary
The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.
Eligibility Criteria
Inclusion
- Weight between 800 - 1500g
- Tolerating enteral feeding within 48 hours
- Having obtained his/her parents or legal representative informed consent
Exclusion
- Chromosomal abnormality
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT00977912
Start Date
November 1 2009
End Date
September 1 2013
Last Update
November 25 2013
Active Locations (3)
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1
University of Witwatersrand & Chris Hani Baragwanath Hospital
Bertsham, South Africa, 2013
2
University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
Johannesburg, South Africa, 2000
3
University of Witwatersrand & Rahima Moosa Mother & Child Hospital
Johannesburg, South Africa, 2112