Prebiotics in the Prevention of Necrotizing Enterocolitis
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|ClinicalTrials.gov Identifier: NCT00437567|
Recruitment Status : Unknown
Verified January 2014 by Cathy Hammerman, Shaare Zedek Medical Center.
Recruitment status was: Recruiting
First Posted : February 21, 2007
Last Update Posted : January 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Necrotizing Enterocolitis||Dietary Supplement: Galacto-oligosaccharide (GOS) Other: Placebo||Phase 2|
Specifically, we hope to demonstrate that fewer of the babies who are treated with galacto-oligosaccharides (GOS) will develop NEC as compared with controls.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prebiotics vs. Placebo in the Prevention of Necrotizing Enterocolitis in Premature Neonates|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||July 2014|
Active Comparator: Prebiotics
Babies randomized to this arm will receive galacto-oligosaccharide supplements
Dietary Supplement: 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 Comparator: Placebo
Babies randomized to this arm will receive placebo
Similar quantity of sterile water to be added to milk
- Incidence of Necrotizing Enterocolitis [ Time Frame: yearly ]
- fecal calprotectin, urine IFABP [ Time Frame: end of study ]
- NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement] [ Time Frame: yearly ]
- Stool bifidobacteria [ Time Frame: End of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437567
|Contact: Cathy Hammerman, MD||9722 firstname.lastname@example.org|
|Contact: Alona Bin-nun, MD||97250 email@example.com|
|Shaare Zedek Medical Center||Recruiting|
|Jerusalem, Israel, 91031|
|Principal Investigator: Cathy Hammerman, MD|
|Sub-Investigator: Alona Bin-nun, MD|
|Principal Investigator:||Cathy Hammerman, MD||Shaare Zedek Medical Center|