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

Newborn Cleft Lip and Slot Carrier Clinical Trial

— CARTOON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02505360
• Other study ID #: 14-052
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2015
• Last updated: July 21, 2015
• Start date: November 2014

Study information

• Verified date: July 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cleft Lip
• Newborn Cleft Lip and Slot Carrier

Intervention

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

Locations

Country	Name	City	State
France	Service de Chirurgie Maxillo-Faciale	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of concentration of hyaluronic acid as well as in type 1 collagen and 3		Baseline	No