Contribution of PRF in CDH in Children With Prothetic Patch Closure

NCT03861182 | Terminated Phase 3

• 1 other identifier: 7067
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Diaphragmatic Hernias

Outcome Measures

Primary Outcomes (1)

• Comparison of cell colonization between neonate biomaterials and the same biomaterials functionalized by Platelet Rich Fibrin of healthy adult volunteers.

  Analysis of cell colonization after cell culture.

  7 days

Study Arms (2)

Adult Healthy Volunteers

OTHER

Biological: Biological functionalization of the prosthetic materials by PRF

Neonates

OTHER

Biological: Biological functionalization of the prosthetic materials by PRF

Interventions

Biological functionalization of the prosthetic materials by PRF BIOLOGICAL

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.

Adult Healthy Volunteers; Neonates

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67 091, France

Location

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: March 4, 2019
• Study Start: September 12, 2019
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: January 19, 2021

Record last verified: 2019-09

Locations

FR (1)