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NCT Number: NCT06088537

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

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.

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nice - Hôpital Archet 2

Nice, Alpes-Mritimes, 06000, France

Location status: Recruiting

Location contact

Bérengère FRANCOIS-GARRET, MD

CONTACT

[email protected]

0492036365 ext. +33

Emma LAISSAC

CONTACT

mailto:[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Identify risk factors for developing transient neonatal colitis.

    Time frame: 3 years

    To determine these risk factors, the study will compare the characteristics of newborns with allergic protocolitis to cow's milk proteins with those of newborns with transient neonatal colitis.

    The parameters compared between the two groups will be as follows: gestational age at birth, route of delivery, antibiotic therapy prior to rectal bleeding, type of diet (mother's milk or artificial milk) family history of allergy.

Study contacts

Contact information is provided by the study sponsor or research team.

Bérengère FRANCOIS-GARRET, Doctor

CONTACT

[email protected]

492036365 ext. +33

Emma LAISSAC

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: COLON

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 18, 2023
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.