Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422988
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-21
First Post:
2024-04-24
Brief Title:
Do Probiotics Reduce The Risk Of Severe Necrotising Enterocolitis NEC In Infants Born Before 32 Weeks Gestation
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Do Probiotics Reduce The Risk Of Severe Necrotising Enterocolitis NEC In Infants Born Before 32 Weeks Gestation An Observational Study Using Routinely Collected Data
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
Necrotising enterocolitis NEC is one of the leading causes of mortality and morbidity in very preterm infants This study aims to determine whether NEC rates are different between infants who receive probiotics versus infants who do not receive probiotics The study has a retrospective cohort design and will utilise routinely collected data from the UK National Neonatal Research Database NNRD The cohort will comprise all infants born before 32 weeks gestation and cared for in neonatal units in England and Wales between 2016 and 2022 A propensity score matched approach will be used to conduct two comparisons i the risk of necrotising enterocolitis NEC between who do and those who do not receive probiotics in the first 14 days of life ii the risk of NEC between babies who receive the two most common probiotic products used in UK units Labinic and Proprems
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None