Intraventricular HemorrhageHEMO PREMANCT02400853
Research a New Predictive Marker of Intraventricular Hemorrhage in Very Preterm Infants
A study testing Standard cranial echography and Cord blood analysis in people with Intraventricular Hemorrhage, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 to 1 day
- Conditions the study is for
- Intraventricular Hemorrhage
- What is being tested?
- Standard cranial echography and Cord blood analysis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2015to 21 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research a New Predictive Marker of Intraventricular Hemorrhage in Very Preterm Infants: HEMO PREMA Study
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.
Read more
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.
- Conditions
- Intraventricular Hemorrhage
- Being tested
- Standard cranial echography, Cord blood analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard cranial echographyDevice
Standard cranial echography will be done at day 5 day 7 post-birth looking for radiological finding of intraventricular hemorrhage
Cord blood analysisProcedure or surgery
Cord blood will be collected during deliverance and analysed
| Study group | Role | What they receive |
|---|---|---|
| preterm infants with intracranial hemorrhage | Experimental | 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 Receives: Device: Standard cranial echography; Procedure: Cord blood analysis |
| preterm infants without intracranial hemorrhage | Active comparator | 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 Receives: Device: Standard cranial echography; Procedure: Cord blood analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
tPA-PAI-1 Complex rate in cord blood
tPA-PAI-1 Complex rate in cord blood will be analysed in the 2 groups of infants
Measured: day 1
Secondary outcomes (5)
MMP-3 rate in cord blood
MMP-3 rate in cord blood will be analysed in the 2 groups of infants
Measured: day 1
PAI-1 rate in cord blood
PAI-1 rate in cord blood will be analysed in the 2 groups of infants
Measured: day 1
PDGF-CC rate in cord blood
PDGF-CC rate in cord blood will be analysed in the 2 groups of infants
Measured: day 1
675G4 / G5 G11053T PAI-1 Genetic variations sequencing
Polymorphism of specified sequence will be performed in the 2 groups of infants
Measured: day 1
A-922g eNOS Genetic variations sequencing
Polymorphism of specified sequence will be performed in the 2 groups of infants
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study start10 Jul 2015
- Primary completion21 Apr 2020
- Study completion21 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraventricular HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane MARRET, Pr, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400853
- Sponsor's protocol ID
- 2014/061/HP
- Acronym
- HEMO PREMA
- Status last verified
- May 2026
- First submitted
- 2 Mar 2015
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Ducatez F, Tebani A, Abily-Donval L, Snanoudj S, Pilon C, Plichet T, Le Chatelier C, Bekri S, Marret S. New insights and potential biomarkers for intraventricular hemorrhage in extremely premature infant, case-control study. Pediatr Res. 2024 Jul;96(2):395-401. doi: 10.1038/s41390-024-03111-9. Epub 2024 Mar 11.
PubMed 38467704
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research a New Predictive Marker of Intraventricular Hemorrhage in Very Preterm Infants: HEMO PREMA Study
- ClinicalTrials.gov ID
- NCT02400853
- Acronym / sponsor ID
- HEMO PREMA / 2014/061/HP
- Conditions
- Intraventricular Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 10 Jul 2015 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preterm infants with intracranial hemorrhage | Experimental | Device: Standard cranial echography, Procedure: Cord blood analysisCord 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 |
| preterm infants without intracranial hemorrhage | Active comparator | Device: Standard cranial echography, Procedure: Cord blood analysisCord 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 |
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard cranial echographyStandard cranial echography will be done at day 5 day 7 post-birth looking for radiological finding of intraventricular hemorrhage | Device | preterm infants with intracranial hemorrhage, preterm infants without intracranial hemorrhage |
| Cord blood analysisCord blood will be collected during deliverance and analysed | Procedure or surgery | preterm infants with intracranial hemorrhage, preterm infants without intracranial hemorrhage |
Primary outcome
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
5 secondary outcomes
MMP-3 rate in cord blood
Time frame: day 1
PAI-1 rate in cord blood
Time frame: day 1
PDGF-CC rate in cord blood
Time frame: day 1
675G4 / G5 G11053T PAI-1 Genetic variations sequencing
Time frame: day 1
A-922g eNOS Genetic variations sequencing
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Results publication: PubMed 38467704Ducatez F, Tebani A, Abily-Donval L, Snanoudj S, Pilon C, Plichet T, Le Chatelier C, Bekri S, Marret S. New insights and potential biomarkers for intraventricular hemorrhage in extremely premature infant, case-control study. Pediatr Res. 2024 Jul;96(2):395-401. doi: 10.1038/s41390-024-03111-9. Epub 2024 Mar 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane MARRET, Pr principal investigator
UH Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard cranial echography and Cord blood analysis in people with Intraventricular Hemorrhage, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tPA-PAI-1 Complex rate in cord blood (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02400853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.