- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01670916
Probiotics to Prevent NEC - a Historical Control Study
Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Copenhagen, Denmark, 2100
- Department of Neonatology, Rigshospitalet
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Gestational age less than 30 weeks
- Admission during the first 3 days of life
Study Plan
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.
|
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:
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death with NEC
Time Frame: Birth to discharge home
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Death with a review board classification of NEC-II/III
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Birth to discharge home
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Death
Time Frame: Birth to discharge home
|
Birth to discharge home
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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
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Birth to discharge from Rigshospitalet
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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