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Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies

This study is currently recruiting participants.
Verified May 2013 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00977912
First received: September 15, 2009
Last updated: May 15, 2013
Last verified: May 2013
History of Changes

September 15, 2009
May 15, 2013
November 2009
January 2014   (final data collection date for primary outcome measure)
NEC onset [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00977912 on ClinicalTrials.gov Archive Site
Antibiotic administration and stool microbiology [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
Prevention of NEC in Preterm Infants With B. Lactis

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Necrotizing Enterocolitis
  • Dietary Supplement: Probiotic supplementation
    one capsule containing probiotics per day added to milk
  • Dietary Supplement: Milk containing placebo
    one capsule containing placebo per day added to milk
  • Experimental: "Milk" containing B. Lactis
    "Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.
    Intervention: Dietary Supplement: Probiotic supplementation
  • Placebo Comparator: "Milk" containing placebo
    "Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.
    Intervention: Dietary Supplement: Milk containing placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
March 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
up to 48 Hours
Yes
Contact: Peter A. Cooper, MD +27 11 488 4246 peter.cooper@wits.ac.za
South Africa
 
NCT00977912
08.09.INF
No
Nestlé
Nestlé
Not Provided
Principal Investigator: Peter A. Cooper, MD University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
Nestlé
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP