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

C

Caen University Hospital

Status

Unknown

Conditions

Newborn Cleft Lip and Slot Carrier

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

Under 28 days old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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