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

March 7, 2024 updated by: Centre Hospitalier Universitaire de Nice
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All newborns ≤ 28 days corrected age or ≤ 44 amenorrhea weeks corrected age hospitalized in neonatal medicine with isolated rectorrhagia.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2024

Primary Completion (Estimated)

January 24, 2027

Study Completion (Estimated)

January 24, 2027

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 11, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-PP-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Isolated Rectal Bleedings

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe