Probiotics to Prevent NEC - a Historical Control Study

September 30, 2013 updated by: Gorm Greisen, Rigshospitalet, Denmark

Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study

Probiotics is given routinely to infants admitted to the department of neonatology during the first 3 days of life with gestational age less than 30 weeks since March 2010. The incidence of necrotizing enterocolitis Bell stage II and III will be assessed blindly from clinical records. It is hypothesised that the incidence of NEC will decrease. Infants admitted from 1 March 2010 to 28 February 2013 will be compared to infants admitted 1 Dec 2007 to 30 Nov 2009 will be compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

714

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

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Neonatology, Rigshospitalet

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

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborn infants admitted for special or intensive care

Description

Inclusion Criteria:

  • Gestational age less than 30 weeks
  • Admission during the first 3 days of life

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

  • Observational Models: Case-Control

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Probiotics
Capsule with 1 x 10**9 Lactobacillus rhamnosus GG and 1 x 10**8 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube.
Dietary supplement: probiotics
Capsule with 1 x 10**9 Lactobacillus rhamnosus GG and 1 x 10**8 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube.
Other Names:
  • Bifiform, Ferrosan A/S
  • Idoform, Ferronan A/S
Control
Probiotics never given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NEC
Time Frame: From birth until discharge home

The clinical records of infants who had a discharge diagnosis of necrotizing enterocolitis are selected. Records of infants who had a prescription of metronidazole for a non-preventive purpose is added. The clinical records are abstracted. The abstracts and X-rays are presented to a review board that are blinded to the period of birth. The board classifies the cases as NEC-I, NEC-II, NEC-III, focal intestinal perforation, and OTHER.

NEC-II/III is the primary outcome.
From birth until discharge home

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death with NEC
Time Frame: Birth to discharge home
Death with a review board classification of NEC-II/III
Birth to discharge home
Death
Time Frame: Birth to discharge home
Birth to discharge home

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive culture of probiotic bacteria
Time Frame: Birth to discharge from Rigshospitalet
Growth of lactobacilli or bifidobacteria from a normally sterile fluid
Birth to discharge from Rigshospitalet

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

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

March 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

August 17, 2012

First Submitted That Met QC Criteria

August 21, 2012

First Posted (Estimate)

August 22, 2012

Study Record Updates

Last Update Posted (Estimate)

October 7, 2013

Last Update Submitted That Met QC Criteria

September 30, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHNEO-NEC01

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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