Development of Child With Equinus Deformity Idiopathic (DENEBO1)

December 18, 2017 updated by: Rennes University Hospital
Identification and characterization of the link between psychomotor development and the appearance of associated signs in children with "Equinus Deformity " considered isolated at birth.

Study Overview

Status

Completed

Conditions

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 ...).

Study Type

Observational

Enrollment (Actual)

112

Contacts and Locations

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

Study Locations

  • France
      • Rennes, France, 35000
        • Rennes University Hospital

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

2 years to 15 years (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with Equinus Deformity

Description

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

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

Collaborators and Investigators

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

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Laurent Pasquier, Rennes University Hospital

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)

June 1, 2017

Primary Completion (ACTUAL)

August 31, 2017

Study Completion (ACTUAL)

August 31, 2017

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

December 18, 2017

First Posted (ACTUAL)

December 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2017

Last Update Submitted That Met QC Criteria

December 18, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC16_3061-DENEBO1
  • 2016-A01975-46 (OTHER: committee for the protection of persons ile de france III)

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.

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