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

November 22, 2013 updated by: Nestlé

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

318

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Bertsham, South Africa, 2013
        • University of Witwatersrand & Chris Hani Baragwanath Hospital
      • Johannesburg, South Africa, 2000
        • University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
      • Johannesburg, South Africa, 2112
        • University of Witwatersrand & Rahima Moosa Mother & Child Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 hours to 2 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
NEC onset
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Antibiotic administration and stool microbiology
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Peter A. Cooper, MD, University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 15, 2009

First Submitted That Met QC Criteria

September 15, 2009

First Posted (Estimate)

September 16, 2009

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 22, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08.09.INF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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