Clinical Trials in France / NCT06088537
Recruiting
Observational
Isolated Rectal Bleeding in Newborns : Allergic Proctocolitis or Neonatal Colitis Transient - COLON Study
NCT06088537 · tracked via the Priya Life Science France tracker
Condition(s) studied
Isolated Rectal Bleedings
Study 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.
Eligibility
Inclusion Criteria:
1. All newborns ≤ 28 days corrected age or ≤ 44 amenorrhea weeks corrected age hospitalized in neonatal medicine with isolated rectorrhagia;
2. Affiliated to social security ;
3. 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);
4. After obtaining the biological mother's non-objection;
Exclusion Criteria:
1. All newborns with ulcerative enterocolitis, congenital digestive malformations or rectorrhagia following digestive surgery;
2. Opposition to participation in research involving the human person.
Primary outcome measure(s)
- Number of newborns allergic to cow's milk protein and hospitalized in neonatal medicine at Nice University Hospital with isolated rectorrhagia. — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Nice - Hôpital Archet 2 | Nice | Alpes-Mritimes | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06088537 on ClinicalTrials.gov ↗ ← All trials in France