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Research a New Predictive Marker of Intraventricular Hemorrhage in Very Preterm Infants (HEMO PREMA)

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ClinicalTrials.gov Identifier: NCT02400853
Recruitment Status : Unknown
Verified December 2016 by University Hospital, Rouen.
Recruitment status was:  Recruiting
First Posted : March 27, 2015
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:

The most frequent complications in premature infants are neurological complications: intracranial hemorrhages and white matter lesions. In Epipage 2 study the incidence of severe intraventricular hemorrhages remains stable. Severe hemorrhages are associated with neurological sequelae.

A recent study in humans and in animals shows the role of the complex formed by plasminogen activator (t-PA) and its inhibitor (PAI-1) in the induction of vascular fragility via stromelysin (MMP-3). FIBRINAT study in Rouen University Hospital showed a rate of complex t-PA-PAI1 probably very high in preterm infants. An other factor maturation PDGF-C induced by t-PA is associated with the vascular embrittlement. Among the few genetic factors associated with cerebral palsy include 2 SNP of PAI-1 gene and one SNP in the gene of endothelial NO synthase.

The hypothesis is that a high rate of the complex t-PA-PAI-1 in cord blood could be a high risk of intracranial hemorrhage in preterm infants and provide predictive of their occurrence. The rates of MMP-3, PDGF-C and PAI-1 free in cord blood, and the polymorphism of PAI-1 gene and eNOS could separately or associated with the main criterion to identify predictive of hemorrhages.

The main objective is to search a rate difference of the complex t-PA-PAI-1 in cord blood of preterm infants (before 30 weeks of gestation) that would predict intracranial hemorrhage coming in the first days of life.

The secondary objectives are

  • Evaluate potential marker risk of high levels of MMP-3, PAI-1 free, and PDGF-CC
  • Search in both groups the presence of alleles -675G4 / G5 and 11053 (G / T) of the PAI-1 gene and -922 (A / G) of the eNOS gene.

    120 preterm infants will be included before 30 weeks of gestation with precise inclusion and exclusion criteria during a period of 3 years.

Patients will be divided into two groups according to whether they will or not showed intracranial hemorrhage (detected by ultrasound J5-J7).

The complex rate tPA-PAI-1, PAI-1 free, MMP-3 and PDGF-C will be measured. The comparison between the two groups will be carried out using statistical tests. Comparison of the presence of the alleles -675 4G and 11053T the PAI-1 gene or -922G eNOS gene between the two groups will be performed.

The demonstration of this hypothesis would permit to identify children from birth in whom the immediate implementation of preventive treatment of bleeding is desirable.


Condition or disease Intervention/treatment Phase
Intraventricular Hemorrhage Device: Standard cranial echography Procedure: Cord blood analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Research a New Predictive Marker of Intraventricular Hemorrhage in Very Preterm Infants: HEMO PREMA Study
Study Start Date : July 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: preterm infants with intracranial hemorrhage
Cord blood analysis of preterm infants with radiological finding of intracranial hemorrhage, detected by ultrasound between day 5 and day 7 post-birth (Standard cranial echography) will be collected and analysed
Device: Standard cranial echography
Standard cranial echography will be done at day 5 day 7 post-birth looking for radiological finding of intraventricular hemorrhage

Procedure: Cord blood analysis
Cord blood will be collected during deliverance and analysed

Active Comparator: preterm infants without intracranial hemorrhage
Cord blood analysis of preterm infants without radiological finding of intracranial hemorrhage, detected by ultrasound between day 5 and day 7 post-birth (Standard cranial echography) will be collected and analysed
Device: Standard cranial echography
Standard cranial echography will be done at day 5 day 7 post-birth looking for radiological finding of intraventricular hemorrhage

Procedure: Cord blood analysis
Cord blood will be collected during deliverance and analysed




Primary Outcome Measures :
  1. tPA-PAI-1 Complex rate in cord blood [ Time Frame: day 1 ]
    tPA-PAI-1 Complex rate in cord blood will be analysed in the 2 groups of infants


Secondary Outcome Measures :
  1. MMP-3 rate in cord blood [ Time Frame: day 1 ]
    MMP-3 rate in cord blood will be analysed in the 2 groups of infants

  2. PAI-1 rate in cord blood [ Time Frame: day 1 ]
    PAI-1 rate in cord blood will be analysed in the 2 groups of infants

  3. PDGF-CC rate in cord blood [ Time Frame: day 1 ]
    PDGF-CC rate in cord blood will be analysed in the 2 groups of infants

  4. 675G4 / G5 G11053T PAI-1 Genetic variations sequencing [ Time Frame: day 1 ]
    Polymorphism of specified sequence will be performed in the 2 groups of infants

  5. A-922g eNOS Genetic variations sequencing [ Time Frame: day 1 ]
    Polymorphism of specified sequence will be performed in the 2 groups of infants



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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alive preterm infants between 24 weeks gestation and 29 weeks and 6 days
  • Infants of both sexes
  • Children whose parents signed a free and informed consent after oral information by one of the study investigators
  • Exact term (pregnancy onset evaluated by the craniocaudal length or the date of the puncture in a medical assisted reproduction)
  • Children with social protection

Exclusion Criteria:

  • Maternal taking of antiplatelet therapy or anticoagulation within 48 hours of birth
  • Acquired maternal disease constituting a risk factor for neonatal hemorrhage
  • Constitutional maternal disease constituting a risk factor for neonatal hemorrhage
  • Severe fetal malformation
  • Cesarean birth after diagnosis of hydrocephalus detected in utero
  • Minors parents
  • History of mental disease,or sensory abnormality of one of the parents, which can lead to confusion about the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400853


Contacts
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Contact: Lénaïg DONVAL, MD lenaig.donval@gmail.com
Contact: Julien BLOT julien.blot@chu-rouen.fr

Locations
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France
Rouen University Hospital Recruiting
Rouen, France, 76031
Contact: Lénaïg DONVAL, MD         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Stéphane MARRET, Pr UH Rouen

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02400853     History of Changes
Other Study ID Numbers: 2014/061/HP
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
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Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases