Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-02 @ 9:38 AM
Study NCT ID:
NCT06501404
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2024-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis
Sponsor:
José Antonio Hurtado Suazo
Organization:
Study Overview
Official Title:
Effects of Probiotic Supplementation During the Neonatal Period on the Preterm Infant
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
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:
The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: