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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

Tracking Information
First Submitted Date  ICMJE March 2, 2015
First Posted Date  ICMJE March 27, 2015
Last Update Posted Date December 7, 2016
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02400853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
  • 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
  • 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
  • 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
  • 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
  • A-922g eNOS Genetic variations sequencing [ Time Frame: day 1 ]
    Polymorphism of specified sequence will be performed in the 2 groups of infants
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Research a New Predictive Marker of Intraventricular Hemorrhage in Very Preterm Infants
Official Title  ICMJE Research a New Predictive Marker of Intraventricular Hemorrhage in Very Preterm Infants: HEMO PREMA Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Intraventricular Hemorrhage
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Device: Standard cranial echography
    • Procedure: Cord blood analysis
  • 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
    Interventions:
    • Device: Standard cranial echography
    • Procedure: Cord blood analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 23, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Day   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02400853
Other Study ID Numbers  ICMJE 2014/061/HP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Rouen
Study Sponsor  ICMJE University Hospital, Rouen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stéphane MARRET, Pr UH Rouen
PRS Account University Hospital, Rouen
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP