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

Primary Purpose

Newborn Cleft Lip and Slot Carrier

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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

About this trial

This is an interventional supportive care trial for Newborn Cleft Lip and Slot Carrier

Eligibility Criteria

undefined - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Service de Chirurgie Maxillo-FacialeRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

nasal and ear cartilage taken from the newborn

Arm Description

to compare biochemical and histological characteristics of both nasal and ear cartilage taken from the newborn at the time of surgical time cheilorhinoplasty

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02505360

First Posted

July 21, 2015

Last Updated

July 21, 2015

Sponsor

University Hospital, Caen

1. Study Identification

Unique Protocol Identification Number

NCT02505360

Brief Title

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

Acronym

CARTOON

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

November 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Caen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Newborn Cleft Lip and Slot Carrier

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

nasal and ear cartilage taken from the newborn

Arm Type

Other

Arm Description

to compare biochemical and histological characteristics of both nasal and ear cartilage taken from the newborn at the time of surgical time cheilorhinoplasty

Intervention Type

Other

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline

10. Eligibility

Sex

All

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Service de Chirurgie Maxillo-Faciale

City

Caen

ZIP/Postal Code

14000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexis VESSYERE, MD

Phone

02.31.06.48.15

veyssiere-a@chu-caen.fr

12. IPD Sharing Statement

Learn more about this trial

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

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