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NCT04983069 Clinical Trial

Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity

Nephropathy Clinical Trial

— COLONECHOGENE  

Official title:
Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04983069
Other study ID # RECHMPL21_0376
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date May 1, 2022

Study information
Verified date November 2021
Source University Hospital, Montpellier
Contact Florent FUCHS, PhD
Phone 04 67 33 09 80
Email f-fuchs@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postnatal outcome of fetuses Postnatal outcome of fetuses with hyperechogenic colon. day 1 (End of follow up)
Secondary Rate of lysinuria/cystinuria Rate of lysinuria/cystinuria day 1 (End of follow up)
Secondary Rate of dibasic protein intolerance Rate of dibasic protein intolerance day 1 (End of follow up)
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