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

Prevention of NEC in Preterm Infants With B. Lactis

Sponsors

Lead Sponsor: Nestlé

Source Nestlé
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.

Overall Status Terminated
Start Date November 2009
Completion Date September 2013
Primary Completion Date September 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
NEC onset 6 weeks
Secondary Outcome
Measure Time Frame
Antibiotic administration and stool microbiology 6 weeks
Enrollment 318
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Probiotic supplementation

Description: one capsule containing probiotics per day added to milk

Arm Group Label: "Milk" containing B. Lactis

Intervention Type: Dietary Supplement

Intervention Name: Milk containing placebo

Description: one capsule containing placebo per day added to milk

Arm Group Label: "Milk" containing placebo

Eligibility

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

Gender: All

Minimum Age: N/A

Maximum Age: 48 Hours

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Peter A. Cooper, MD Principal Investigator University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
Location
Facility:
University of Witwatersrand & Chris Hani Baragwanath Hospital | Bertsham, 2013, South Africa
University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital | Johannesburg, 2000, South Africa
University of Witwatersrand & Rahima Moosa Mother & Child Hospital | Johannesburg, 2112, South Africa
Location Countries

South Africa

Verification Date

November 2013

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: "Milk" containing B. Lactis

Type: Experimental

Description: "Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.

Label: "Milk" containing placebo

Type: Placebo Comparator

Description: "Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov