Neonatal Outcome of Children With Antenatal Colic Hyperec... | NCT04983069

Studies
Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity

NCT04983069

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Nov 15, 2021Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Colic
Nephropathy

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

May 1, 2022Estimated

Completion Date

May 1, 2022Estimated

First Submitted Date

Jul 5, 2021

First Submission Date that Met QC Criteria

Jul 19, 2021

First Posted Date

Jul 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2021

Last Update Posted Date

Nov 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Foetuses with prenatal colic hyperechogenicity

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Florent FUCHS, PhD	Contact	04 67 33 09 80	33	f-fuchs@chu-montpellier.fr
Alexis RODRIGUEZ, resident	Contact	668591043	33	alexis-rodriguez@chu-montpellier.fr

Overall Officials

Name	Affiliation	Role
Florent FUCHS, PhD	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier	Recruiting	Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003085	Colic
D007674	Kidney Diseases
C562687	Lysinuric Protein Intolerance

Ancestor Terms

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided