Status:
RECRUITING
Isolated Rectal Bleeding in Newborns : Allergic Proctocolitis or Neonatal Colitis Transient - COLON Study
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Isolated Rectal Bleedings
Eligibility:
All Genders
1-28 years
Brief Summary
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...
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 bi...
Eligibility Criteria
Inclusion
- All newborns ≤ 28 days corrected age or ≤ 44 amenorrhea weeks corrected age hospitalized in neonatal medicine with isolated rectorrhagia;
- Affiliated to social security ;
- Presenting isolated rectorrhagia defined as rectorrhagia without hematemesis/ repeated vomiting/ tense or distended abdomen/ apathy/ apnea/ bradycardia or signs of severity (tachycardia, desaturation, poor coloration);
- After obtaining the biological mother's non-objection;
Exclusion
- All newborns with ulcerative enterocolitis, congenital digestive malformations or rectorrhagia following digestive surgery;
- Opposition to participation in research involving the human person.
Key Trial Info
Start Date :
January 24 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 24 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06088537
Start Date
January 24 2024
End Date
July 24 2027
Last Update
June 19 2025
Active Locations (1)
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1
CHU Nice - Hôpital Archet 2
Nice, Alpes-Mritimes, France, 06000