Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
Not Applicable
Terminated
- Conditions
- Necrotizing Enterocolitis
- Registration Number
- NCT00977912
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 318
Inclusion Criteria
- Weight between 800 - 1500g
- Tolerating enteral feeding within 48 hours
- Having obtained his/her parents or legal representative informed consent
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method NEC onset 6 weeks
- Secondary Outcome Measures
Name Time Method Antibiotic administration and stool microbiology 6 weeks
Trial Locations
- Locations (3)
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
University of Witwatersrand & Chris Hani Baragwanath Hospital🇿🇦Bertsham, South Africa