Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity (COLONECHOGENE)

November 12, 2021 updated by: University Hospital, Montpellier

Fetal colic hyper-echogenicity is a presenting symptoms for cystinuria lysinuria.

A few cases of fetuses with dibasic protein intolerance (more complex prognosis) presented with colic hyper-echogenicity antenatal.

The aim of this retrospective study is to assess the outcome of fetuses with colic hyperechogenicity in order to increase prenatal counseling

Study Overview

Status

Recruiting

Conditions

Detailed Description

Observational multicenter retrospective study from january 2011 to january 2021.

No supplementary visit, directly related to the research, will be necessary. This study does not change the usual management of the patient.

Patients will be included after their usual medical check-up.

Study Type

Observational

Enrollment (Anticipated)

400

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

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Foetuses with prenatal colic hyperechogenicity

Description

Inclusion criteria:

  • Fetuses with prenatal colic hyperechogenicity
  • Between January 2011 and January 2021
  • Born without term limitation.

Exclusion criteria:

  • Intestinal hyperechogenicity
  • polymalformative syndrome
  • Patients Age<15 years

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
Postnatal outcome of fetuses
Time Frame: day 1 (End of follow up)
Postnatal outcome of fetuses with hyperechogenic colon.
day 1 (End of follow up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of lysinuria/cystinuria
Time Frame: day 1 (End of follow up)
Rate of lysinuria/cystinuria
day 1 (End of follow up)
Rate of dibasic protein intolerance
Time Frame: day 1 (End of follow up)
Rate of dibasic protein intolerance
day 1 (End of follow up)

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Florent FUCHS, PhD, University Hospital, Montpellier

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)

July 1, 2021

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL21_0376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

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.

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