NCT06088537

Isolated Rectal Bleeding in Newborns : Allergic Proctocolitis or Neonatal Colitis Transient - COLON Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Not accepted

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 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 cow's milk proteins. Prospective observational study of current practices without any intervention.

Conditions

• Isolated Rectal Bleedings

Timeline

• Start date: 2024-01-24
• Primary completion: 2027-07-24
• Completion: 2027-07-24
• First posted: 2023-10-18
• Last updated: 2026-01-23

Locations

1 site across 1 country: France