Contribution of PRF in CDH in Children With Prothetic Patch Closure (HECODIAP)

University Hospital, Strasbourg, France

Status and phase: Terminated; Phase 3

Conditions: Congenital Diaphragmatic Hernias

Treatments: Biological: Biological functionalization of the prosthetic materials by PRF

Study type: Interventional

Funder types: Other

Identifiers

NCT03861182

7067

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 1+ day old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Adult Healthy Volunteers

Other group

Treatment:

Biological: Biological functionalization of the prosthetic materials by PRF

Neonates

Other group

Treatment:

Biological: Biological functionalization of the prosthetic materials by PRF