Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437567
Status:
UNKNOWN
Last Update Posted:
2014-01-03
First Post:
2007-02-08
Brief Title:
Prebiotics in the Prevention of Necrotizing Enterocolitis
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
Official Title:
Prebiotics vs Placebo in the Prevention of Necrotizing Enterocolitis in Premature Neonates
Status:
UNKNOWN
Status Verified Date:
2014-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Necrotizing enterocolitis NEC is the most common gastrointestinal catastrophe affecting 10-15 of premature neonates of 1500 gm NEC is a disease of the immature intestine characterized by impaired mucosal barrier function leading to increased gut permeability We have previously demonstrated a protective effect of probiotic administration against the development of NEC Others have shown that prebiotics can stimulate natural production of bifidobacteria and lactobacillus in the preterm gut We have therefore hypothesized that prophylactic administration of prebiotics would also provide protection against necrotizing enterocolitis in the premature neonate without the potential for sepsis which has been reported on rare occasions with probiotics administration
Detailed Description:
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 andor development of NEC These will be compared between the two groups
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 andor development of NEC These will be compared between the two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None