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

NCT00977912 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2013-11-25

No results posted yet for this study

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.

Conditions

  • Necrotizing Enterocolitis

Interventions

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

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Hours
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00977912 on ClinicalTrials.gov