search
Back to results

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

Primary Purpose

Necrotizing Enterocolitis

Status
Terminated
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Probiotic supplementation
Milk containing placebo
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Necrotizing Enterocolitis focused on measuring B. lactis, Preterm, Necrotizing Enterocolitis (NEC)

Eligibility Criteria

12 Hours - 48 Hours (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Witwatersrand & Chris Hani Baragwanath Hospital
  • University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
  • University of Witwatersrand & Rahima Moosa Mother & Child Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

"Milk" containing B. Lactis

"Milk" containing placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

NEC onset

Secondary Outcome Measures

Antibiotic administration and stool microbiology

Full Information

First Posted
September 15, 2009
Last Updated
November 22, 2013
Sponsor
Société des Produits Nestlé (SPN)
search

1. Study Identification

Unique Protocol Identification Number
NCT00977912
Brief Title
Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
Official Title
Prevention of NEC in Preterm Infants With B. Lactis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis
Keywords
B. lactis, Preterm, Necrotizing Enterocolitis (NEC)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Milk" containing B. Lactis
Arm Type
Experimental
Arm Description
"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.
Arm Title
"Milk" containing placebo
Arm Type
Placebo Comparator
Arm Description
"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic supplementation
Intervention Description
one capsule containing probiotics per day added to milk
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk containing placebo
Intervention Description
one capsule containing placebo per day added to milk
Primary Outcome Measure Information:
Title
NEC onset
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Antibiotic administration and stool microbiology
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Hours
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A. Cooper, MD
Organizational Affiliation
University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Witwatersrand & Chris Hani Baragwanath Hospital
City
Bertsham
ZIP/Postal Code
2013
Country
South Africa
Facility Name
University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
City
Johannesburg
ZIP/Postal Code
2000
Country
South Africa
Facility Name
University of Witwatersrand & Rahima Moosa Mother & Child Hospital
City
Johannesburg
ZIP/Postal Code
2112
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
33058137
Citation
Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs