Prebiotics in the Prevention of Necrotizing Enterocolitis
NCT ID: NCT00437567
Last Updated: 2014-01-03
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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UNKNOWN
PHASE2
260 participants
INTERVENTIONAL
2009-07-31
2014-07-31
Brief Summary
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Detailed Description
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Preterm neonates, \<1750 gm birth weight will potentially be candidates for study. They will be randomly assigned to receive one of two milk additives from the time enteral feeds are begun until 35 weeks post-conceptual age: prebiotics (GOS) or placebo (water). All infants will be followed prospectively for signs of feeding intolerance and/or development of NEC. These will be compared between the two groups.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
QUADRUPLE
Study Groups
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Prebiotics
Babies randomized to this arm will receive galacto-oligosaccharide supplements
Galacto-oligosaccharide (GOS)
Treatment group to receive 1.3 gm/kg/day GOS from initiation of enteral feeds until 35 weeks post-conceptual age.
Placebo
Babies randomized to this arm will receive placebo
Placebo
Similar quantity of sterile water to be added to milk
Interventions
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Galacto-oligosaccharide (GOS)
Treatment group to receive 1.3 gm/kg/day GOS from initiation of enteral feeds until 35 weeks post-conceptual age.
Placebo
Similar quantity of sterile water to be added to milk
Eligibility Criteria
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Inclusion Criteria
* \< 1750 gm birth weight
Exclusion Criteria
* Infants with significant congenital malformations
* Infants with other gastrointestinal problems
7 Days
ALL
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Cathy Hammerman
Professor of Pediatrics
Principal Investigators
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Cathy Hammerman, MD
Role: PRINCIPAL_INVESTIGATOR
Shaare Zedek Medical Center
Locations
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Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
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Central Contacts
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References
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Bin-Nun A, Bromiker R, Wilschanski M, Kaplan M, Rudensky B, Caplan M, Hammerman C. Oral probiotics prevent necrotizing enterocolitis in very low birth weight neonates. J Pediatr. 2005 Aug;147(2):192-6. doi: 10.1016/j.jpeds.2005.03.054.
Other Identifiers
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SZMC/CH/32007
Identifier Type: -
Identifier Source: org_study_id
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