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

NCT ID: NCT02505360

Last Updated: 2015-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30

Brief Summary

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.

Conditions

Newborn Cleft Lip and Slot Carrier

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Measurements of concentration of hyaluronic acid as well as in type 1 collagen and 3

Intervention Type: OTHER

Interventions

Measurements of concentration of hyaluronic acid as well as in type 1 collagen and 3

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de Chirurgie Maxillo-Faciale

Caen, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Alexis VESSYERE, MD

Role: primary

veyssiere-a@chu-caen.fr

02.31.06.48.15

Other Identifiers

14-052

Identifier Type: -

Identifier Source: org_study_id