Development of Child With Equinus Deformity Idiopathic | NCT03382028

Studies
Development of Child With Equinus Deformity Idiopathic

NCT03382028

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Dec 22, 2017Actual

Enrollment

112Actual

Phase

Not provided

Conditions

Equinus Deformity

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

ID	Type	Description	Link
2016-A01975-46	Other Identifier	committee for the protection of persons ile de france III

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Aug 31, 2017Actual

Completion Date

Aug 31, 2017Actual

First Submitted Date

Nov 16, 2017

First Submission Date that Met QC Criteria

Dec 18, 2017

First Posted Date

Dec 22, 2017Actual

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

Dec 18, 2017

Last Update Posted Date

Dec 22, 2017Actual

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

Identification and characterization of the link between psychomotor development and the appearance of associated signs in children with "Equinus Deformity " considered isolated at birth.

Detailed Description

The main objective of this study is to define the frequency of developmental abnormalities in children with "Equinus Deformity Idiopathic" compared to the general population

The secondary objective is to identify the prenatal and / or neonatal characteristics that could be predictive of the occurrence of developmental abnormalities in

Prenatal and postnatal follow-up data are derived from the child's medical file. To complete these data and after inclusion, parents of children carrying "Equinus Deformity Idiopathic" will be sent a questionnaire that assesses overall psychomotor development and lists the medical events since the birth of their child (scoliosis, epilepsy ...).

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

112Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of developmental abnormalities (with the exception of Equinus Deformity) in children with Equinus Deformity idiopathic compared to the general population.		through study completion an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children born between January 2002 and August 2015
Prenatal or postnatal diagnosis of idiopathic or syndromic Equinus Deformity
Followed by the pediatric orthopedic service of Rennes University Hospital
Parent having received the information on the protocol and having not expressed their opposition.

Exclusion Criteria:

Parents opposing the study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Children with Equinus Deformity

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laurent Pasquier	Rennes University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rennes University Hospital		Rennes		35000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004863	Equinus Deformity

Ancestor Terms

ID	Term
D000070558	Talipes
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided