Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06088537
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-10-05
Brief Title:
Isolated Rectal Bleeding in Newborns Allergic Proctocolitis or Neonatal Colitis Transient - COLON Study
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Isolated Rectal Bleeding in Newborns Allergic Proctocolitis or Neonatal Colitis Transient - COLON Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
COLON
Brief Summary:
Prospective observational pilot study evaluating the frequency of cows milk protein allergic prococolitis in newborns hospitalized in neontal medicine at the university hospital of Nice who presented rectal bleeding
Detailed Description:
Inclusion of all newborns in the neonatal medicine department at Nice University Hospital with isolated rectal bleeding
A note of information and non-opposition will be presented and given to the biological mother She has the right to object to this study on her own initiative at any time
Collection of data relating to the newborn during hospitalization the results of the clinical examination and the systematic check-up carried out in accordance with standard practice and data at discharge
Follow-up of the newborn to determine the cause of rectal bleeding and therefore the frequency of procolitis allergic to cows milk proteins
Prospective observational study of current practices without any intervention
A note of information and non-opposition will be presented and given to the biological mother She has the right to object to this study on her own initiative at any time
Collection of data relating to the newborn during hospitalization the results of the clinical examination and the systematic check-up carried out in accordance with standard practice and data at discharge
Follow-up of the newborn to determine the cause of rectal bleeding and therefore the frequency of procolitis allergic to cows milk proteins
Prospective observational study of current practices without any intervention
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