Isolated Rectal Bleeding in Newborns : Allergic Proctocolitis or Neonatal Colitis Transient - COLON Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Isolated Rectal Bleedings. Basic parameters: 1 Day — 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Number of newborns allergic to cow's milk protein and hospitalized in neonatal medicine at Nice University Hospital with isolated rectorrhagia. [Time frame: 3 years]
Secondary outcome measures (1)
- Identify risk factors for developing transient neonatal colitis. [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- All newborns with ulcerative enterocolitis, congenital digestive malformations or rectorrhagia following digestive surgery;
- Opposition to participation in research involving the human person.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 1 center
- CHU Nice - Hôpital Archet 2 — Nice
Identifiers
NCT: NCT06088537 · 23-PP-05