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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00977912
First received: September 15, 2009
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Necrotizing Enterocolitis
Dietary Supplement: Probiotic supplementation
Dietary Supplement: Milk containing placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of NEC in Preterm Infants With B. Lactis

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • NEC onset [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antibiotic administration and stool microbiology [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 318
Study Start Date: November 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: "Milk" containing B. Lactis
"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.
Dietary Supplement: Probiotic supplementation
one capsule containing probiotics per day added to milk
Placebo Comparator: "Milk" containing placebo
"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.
Dietary Supplement: Milk containing placebo
one capsule containing placebo per day added to milk

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977912

Locations
South Africa
University of Witwatersrand & Chris Hani Baragwanath Hospital
Bertsham, South Africa, 2013
University of Witwatersrand & Rahima Moosa Mother & Child Hospital
Johannesburg, South Africa, 2112
University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
Johannesburg, South Africa, 2000
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Peter A. Cooper, MD University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00977912     History of Changes
Other Study ID Numbers: 08.09.INF
Study First Received: September 15, 2009
Last Updated: November 22, 2013
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by Nestlé:
B. lactis
Preterm
Necrotizing Enterocolitis (NEC)

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 16, 2014