Congenital Diaphragmatic Hernias
Conditions
Brief summary
Improved management of giant congenital diaphragmatic hernias (CDH) in neonates : decreased risk of morbidity and mortality due to prosthesis release. CDH is a rare disease with a still very dark prognosis, with a high rate of morbidity and mortality in giants forms linked to the release of insufficiently biologically integrated prosthesis. The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.
Interventions
BIOLOGICALBiological functionalization of the prosthetic materials by PRF
The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to No maximum
Healthy volunteers
Yes
Inclusion criteria
Adult Healthy Volunteers : \- Over 18 years of age Neonates: * Aged between 1h of life and 28 days of life * Born beyond 33 Week of Amenorrhea + 1day and 2kg of birth weight * Hospitalized in the medical-surgical centre of Pediatrics of the hospital of Strasbourg * For whom a blood sample was prescribed as part of their routine care
Exclusion criteria
Adult Healthy Volunteers : * Systemic inflammatory disease * Transient inflammatory state * Any drug that modifies the coagulation cascade during the 48h preceding the sampling Neonates: * Risk of anemia \< 7g/DL * Current anticoagulant treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of cell colonization between neonate biomaterials and the same biomaterials functionalized by Platelet Rich Fibrin of healthy adult volunteers. | 7 days | Analysis of cell colonization after cell culture. |
Countries
France
Outcome results
None listed