Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
714 participants
OBSERVATIONAL
2010-03-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
Study Groups
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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.
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.
Control
Probiotics never given
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admission during the first 3 days of life
3 Days
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Gorm Greisen
professor, consultant neonatologist
Locations
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Department of Neonatology, Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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Lambaek ID, Fonnest G, Gormsen M, Brok J, Greisen G. Probiotics to prevent necrotising enterocolitis in very preterm infants. Dan Med J. 2016 Mar;63(3):A5203.
Other Identifiers
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RHNEO-NEC01
Identifier Type: -
Identifier Source: org_study_id