Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
This study is currently recruiting participants.
Verified May 2013 by Nestlé
Sponsor:
Nestlé
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00977912
First received: September 15, 2009
Last updated: May 15, 2013
Last verified: May 2013
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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 ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | January 2014 (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
Contacts
| Contact: Peter A. Cooper, MD | +27 11 488 4246 | peter.cooper@wits.ac.za |
Locations
| South Africa | |
| University of Witwatersrand & Chris Hani Baragwanath Hospital | Recruiting |
| Bertsham, South Africa, 2013 | |
| Contact: S.C Velaphi, MD +27 11 933 8000 sithembiso.velaphi@wits.ac.za | |
| Principal Investigator: S.C. Velaphi, MD | |
| University of Witwatersrand & Rahima Moosa Mother & Child Hospital | Recruiting |
| Johannesburg, South Africa, 2112 | |
| Contact: Keith D. Bolton, MD +27 11 470 9284 keith.bolton@wits.ac.za | |
| Principal Investigator: Keith D. Bolton, MD | |
| University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital | Recruiting |
| Johannesburg, South Africa, 2000 | |
| Contact: Peter A. Cooper, MD +27 488 4246 peter.cooper@wits.ac.za | |
| Principal Investigator: Peter A. Cooper, MD | |
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: | May 15, 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 May 23, 2013