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

C

Centre Hospitalier Universitaire de Nice

Status

Enrolling

Conditions

Isolated Rectal Bleedings

Study type

Observational

Funder types

Other

Identifiers

NCT06088537
23-PP-05

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

1 to 28 days old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Bérengère FRANCOIS-GARRET, Doctor; Emma LAISSAC

Data sourced from clinicaltrials.gov

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