Biochemical and Histological Comparison of Nasal and Auricular Cartilage in the Fetus and Newborn With Cleft Lip Carrier (CARTOON)

July 21, 2015 updated by: University Hospital, Caen

Comparaison Biochimique et Histologique Des Cartilages Nasal et Auriculaire Chez le fœtus et le Nouveau-né Porteur de Fente Labiale

We seek to compare biochemically and histologically the nasal cartilage and ear in the newborn cleft lip and slot carrier in order to improve the quality of care and patient comfort after surgery of cheilorhinoplasty which is the primary treatment slots .

The concentration of hyaluronic acid as well as in type 1 collagen and 3 are assayed by immunohistochemistry and study of mRNA and then they are compared according to the type of cartilage.

This comparison is done on nasal cartilage samples and atrial newborns holders of cleft lip and operated in the neonatal period.

Given the difficulty and constraint of time it takes to reach the 20 subjects of our study , we will also add to our population the stillborn babies before 25SA and newborns who die before the age of 28 days and having had an autopsy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

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
      • Caen, France, 14000
        • Recruiting
        • Service de Chirurgie Maxillo-Faciale
        • Contact:

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

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants aged 0 to 5 weeks with an isolated cleft lip and palate, that is to say non-syndromic, and that will be operated for cheilorhinoplasty neonatal, whose parents have read and understood the document Information and accepted and signed informed consent,
  • Children born without life before 25SA and whose parents have read and understood the Information and accepted and signed informed consent for diagnostic purposes permission to autopsy and scientific purposes and / or therapeutic.
  • Newborns who died before 28 days of life and whose parents have read and understood the Information and accepted and signed informed consent for diagnostic purposes permission to autopsy and scientific purposes and / or therapeutic.
  • Patients And relatives of patients who received clear information and having signed an informed consent,
  • Patients Benefiting from a health insurance plan

Exclusion Criteria:

  • Patient with no lip slots ( bike palate only or other Tessier slot ) )
  • Patient having slots syndromic cleft lip
  • Patient whose parents refuse entry into the study.
  • Children born without life before 25SA
  • Newborns who died after 28 days of life

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

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: nasal and ear cartilage taken from the newborn
to compare biochemical and histological characteristics of both nasal and ear cartilage taken from the newborn at the time of surgical time cheilorhinoplasty
Other: Measurements of concentration of hyaluronic acid as well as in type 1 collagen and 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurements of concentration of hyaluronic acid as well as in type 1 collagen and 3
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

University Hospital, Caen

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

November 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

July 21, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 21, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-052 (Fox Chase Cancer Center)

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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