CHU Nice - Hôpital Archet 2
Nice, Alpes-Mritimes, 06000, France
Location status: Recruiting
Location contact
Bérengère FRANCOIS-GARRET, MD
CONTACT
0492036365 ext. +33
Emma LAISSAC
CONTACT
mailto:[email protected]
NCT Number: NCT06088537
Prospective observational pilot study evaluating the frequency of cow's milk protein allergic prococolitis in newborns hospitalized in neontal medicine at the university hospital of Nice who presented rectal bleeding.
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Request Info1 day–28 day
All sexes
Observational
Nice, Alpes-Mritimes, 06000, France
Location status: Recruiting
Bérengère FRANCOIS-GARRET, MD
CONTACT
0492036365 ext. +33
Emma LAISSAC
CONTACT
mailto:[email protected]
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 cow's milk proteins.
Prospective observational study of current practices without any intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 years
The main objective of this study is to determine the number of newborns presenting real allergic proctocolitis to cow's milk protein among all newborns hospitalised in neonatal medicine who presented with isolated rectal bleeding in order to determine the frequency of this pathology.
If rectal bleeding disappears when cow's milk proteins are eliminated and reappears when cow's milk proteins are reintroduced, the diagnosis of allergic proctocolitis to cow's milk proteins will be confirmed.
In other cases, newborns will be considered to have had transient neonatal colitis.
Then this study will determine the frequency of these two diseases in the population study.
Time frame: 3 years
To determine these risk factors, the study will compare the characteristics of newborns with allergic protocolitis to cow's milk proteins with those of newborns with transient neonatal colitis.
The parameters compared between the two groups will be as follows: gestational age at birth, route of delivery, antibiotic therapy prior to rectal bleeding, type of diet (mother's milk or artificial milk) family history of allergy.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nice
Other
Acronym: COLON
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.