Children Born Very Prematurely in Relation to Structural Brain AbnormalitiesEPIRMEXNCT02851537
Magnetic Resonance Spectroscopy at Term-equivalent Age and Executive Functions at 5 Years of Age Corrected in Very Preterm Infants
An observational study of Children Born Very Prematurely in Relation to Structural Brain Abnormalities, run by Assistance Publique Hopitaux De Marseille.
Trial summary
EPIRMEX is a complementary study to the national cohort EPIPAGE 2 the INSERM Unit 953 is responsible. The objective of this study is to evaluate at the age of 5 years corrected executive functions in children born very prematurely in relation to structural brain abnormalities in magnetic resonance imaging (MRI)… Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Children Born Very Prematurely in Relation to Structural Brain Abnormalities
- What is being tested?
- an advanced technique as magnetic resonance spectroscopy (MRS)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Jan 2019
- Phase
- Observational
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children born very prematurely in relation to structural brain abnormalities and has received spectroscopy
Who may be able to join
- Preterm infants born between 26+ 0d and 32 SA + 6d.
- Children included in the study EPIPAGE2, and EPIRMEX and has received spectroscopy.
- Regions of interest analyzed: periventricular area, basal ganglia, brain stem.
- Who has full cognitive assessment in epirmex to 5 years.
Who cannot join
- Children with severe chromosomal anomaly.
- Children with central nervous system malformation diagnosed prenatally or on examinations in the neonatal period (transfontanellaire ultrasound and/or MRI).
Trial locations and contacts
No sites are listed yet.
About this study
EPIRMEX is a complementary study to the national cohort EPIPAGE 2 the INSERM Unit 953 is responsible. The objective of this study is to evaluate at the age of 5 years corrected executive functions in children born very prematurely in relation to structural brain abnormalities in magnetic resonance imaging (MRI) (technical conventional and advanced) performed at the age of term. The current study is a project on a subset of the population of premature EPIRMEX subjects who had an advanced technique as magnetic resonance spectroscopy (MRS). It is a recent imaging technique for a study of the cerebral metabolism. It is based on the detection of cerebral metabolites, and the variations of their concentration to characterize different pathologies. In most cases, combinations of metabolites are informed creatine + phosphocreatine (CR), glycerophosphocholine + phosphocholine (CHO) + Nacétylaspartate Nacetylaspartylglutamate (NAA), myoinositol (INS) and lactate (LAC). In the premature newborn, the NAA / CHO ratio increases with age in all brain regions. The LAC / NAA ratio decreases significantly with age in the thalamus, basal ganglia, the corticospinal tract, and parietal white matter tends to decrease elsewhere . A number of studies show that proton spectroscopy term can predict the long-term newborn who presented an anoxic-ischemic encephalopathy .These studies indicate that an increase in lactate and a decrease in NAA are correlated with abnormal neurological development. And decreases in NAA / CR and / or NAA / CHO ratios are predictive of motor abnormalities in children with anoxic encephalopathy presented an ischemia . These decreases were also measured in the basal ganglia, occipital cortex, and areas near the last. Few studies have explored the magnetic resonance spectroscopy of proton-term prediction of the future of large premature.
Read the detailed description
This is a prospective cohort study on a subsample of children born prematurely (before 33 weeks of gestation (SA) otherwise included in the national cohort EPIPAGE 2 and included in epirmex and who enjoys a spectrosocpie. This research project proposed in the framework of the AORC as ancillary study EPIPAGE 2 -EPIRMEX therefore focuses on spectroIRM voluntarily at the age of term (39-41 SA), and more specifically the emergence executive functions to 5 years EPIRMEX main objective of the study. the application of our project to this tender is requested by the PACA region due to the high rate spectroIRM performed by our area (about 75%) and strong involvement of Dr. C. Gire in EPIPAGE 2 and EPIRMEX. However, only neuropsychological assessments FE 5 years testing sub-cities will be funded EPIPAGE 2. The specific aspect of our study is not funded EPIPAGE 2.
The children received conventional MRI at the age of term (39-41 SA), supplemented by specific sequences for single voxel analysis in microstructural analysis (white matter, basal ganglia and brainstem), short echo and echo time consuming. The study of the spectra will be done quantitatively by CEMEREM laboratory - UMR 6612 CNRS / Université de la Méditerranée / Division of Medical Imaging (Pr Guye).
The relevance of the project was its ability to include quality as 550 MRI were performed, including 120 MRI spectrometer can be analyzed.
These children were assessed within 2 EPIPAGE the corrected age of 2 years, 3 years (EPIRMEX) and 5 years (2 + EPIPAGE EPIRMEX). The balance sheet under 5 years in EPIRMEX is evaluating a comprehensive intellectual efficiency WPPSI III, some elements of the NEPSY and the figure of REY.
So magnetic resonance spectroscopy may provide additional diagnostic value to cranial ultrasound and MRI in infants.
The main objective is to assess the relation between the cerebral MRS at term-equivalent age of very preterm infants and the executive functions at the age of 5 years corrected.
- Being tested
- an advanced technique as magnetic resonance spectroscopy (MRS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an advanced technique as magnetic resonance spectroscopy (MRS)Other
subjects who had an advanced technique as magnetic resonance spectroscopy (MRS) It is based on the detection of cerebral metabolites, and the variations of their concentration to characterize different pathologies.
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the executive dysfunction
NEPSY score <-1 DS is <8 (required) it is a tool to assess the neuropsychological development of children of preschool and school age (3 to 12 years)
Measured: one day
intellectual efficiency
Wechsler Preschool and Primary Scale of Intelligence (WPPSI)
Measured: one day
perceptual organization and memory
figure of REY is a short test of perceptual organization and memory. The figure of Rey is called abnormal for a copy <10th percentile.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startOct 2017 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Born Very Prematurely in Relation to Structural Brain AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851537
- Sponsor's protocol ID
- 2015-17
- Acronym
- EPIRMEX
- Status last verified
- Aug 2017
- First submitted
- 28 Jul 2016
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Spectroscopy at Term-equivalent Age and Executive Functions at 5 Years of Age Corrected in Very Preterm Infants
- ClinicalTrials.gov ID
- NCT02851537
- Acronym / sponsor ID
- EPIRMEX / 2015-17
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 1 Aug 2016 (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.
EPIRMEX is a complementary study to the national cohort EPIPAGE 2 the INSERM Unit 953 is responsible. The objective of this study is to evaluate at the age of 5 years corrected executive functions in children born very prematurely in relation to structural brain abnormalities in magnetic resonance imaging (MRI) (technical conventional and advanced) performed at the age of term. The current study is a project on a subset of the population of premature EPIRMEX subjects who had an advanced technique as magnetic resonance spectroscopy (MRS). It is a recent imaging technique for a study of the cerebral metabolism. It is based on the detection of cerebral metabolites, and the variations of their concentration to characterize different pathologies. In most cases, combinations of metabolites are informed creatine + phosphocreatine (CR), glycerophosphocholine + phosphocholine (CHO) + Nacétylaspartate Nacetylaspartylglutamate (NAA), myoinositol (INS) and lactate (LAC). In the premature newborn, the NAA / CHO ratio increases with age in all brain regions. The LAC / NAA ratio decreases significantly with age in the thalamus, basal ganglia, the corticospinal tract, and parietal white matter tends to decrease elsewhere . A number of studies show that proton spectroscopy term can predict the long-term newborn who presented an anoxic-ischemic encephalopathy .These studies indicate that an increase in lactate and a decrease in NAA are correlated with abnormal neurological development. And decreases in NAA / CR and / or NAA / CHO ratios are predictive of motor abnormalities in children with anoxic encephalopathy presented an ischemia . These decreases were also measured in the basal ganglia, occipital cortex, and areas near the last. Few studies have explored the magnetic resonance spectroscopy of proton-term prediction of the future of large premature.
Detailed description
This is a prospective cohort study on a subsample of children born prematurely (before 33 weeks of gestation (SA) otherwise included in the national cohort EPIPAGE 2 and included in epirmex and who enjoys a spectrosocpie. This research project proposed in the framework of the AORC as ancillary study EPIPAGE 2 -EPIRMEX therefore focuses on spectroIRM voluntarily at the age of term (39-41 SA), and more specifically the emergence executive functions to 5 years EPIRMEX main objective of the study. the application of our project to this tender is requested by the PACA region due to the high rate spectroIRM performed by our area (about 75%) and strong involvement of Dr. C. Gire in EPIPAGE 2 and EPIRMEX. However, only neuropsychological assessments FE 5 years testing sub-cities will be funded EPIPAGE 2. The specific aspect of our study is not funded EPIPAGE 2.
The children received conventional MRI at the age of term (39-41 SA), supplemented by specific sequences for single voxel analysis in microstructural analysis (white matter, basal ganglia and brainstem), short echo and echo time consuming. The study of the spectra will be done quantitatively by CEMEREM laboratory - UMR 6612 CNRS / Université de la Méditerranée / Division of Medical Imaging (Pr Guye).
The relevance of the project was its ability to include quality as 550 MRI were performed, including 120 MRI spectrometer can be analyzed.
These children were assessed within 2 EPIPAGE the corrected age of 2 years, 3 years (EPIRMEX) and 5 years (2 + EPIPAGE EPIRMEX). The balance sheet under 5 years in EPIRMEX is evaluating a comprehensive intellectual efficiency WPPSI III, some elements of the NEPSY and the figure of REY.
So magnetic resonance spectroscopy may provide additional diagnostic value to cranial ultrasound and MRI in infants.
The main objective is to assess the relation between the cerebral MRS at term-equivalent age of very preterm infants and the executive functions at the age of 5 years corrected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children born very prematurely in relation to structural brain abnormalities and has received spectroscopy
Key inclusion criteria (4 listed)
- Preterm infants born between 26+ 0d and 32 SA + 6d.
- Children included in the study EPIPAGE2, and EPIRMEX and has received spectroscopy.
- Regions of interest analyzed: periventricular area, basal ganglia, brain stem.
- Who has full cognitive assessment in epirmex to 5 years.
Key exclusion criteria (2 listed)
- Children with severe chromosomal anomaly.
- Children with central nervous system malformation diagnosed prenatally or on examinations in the neonatal period (transfontanellaire ultrasound and/or MRI).
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 |
|---|---|---|
| an advanced technique as magnetic resonance spectroscopy (MRS)subjects who had an advanced technique as magnetic resonance spectroscopy (MRS) It is based on the detection of cerebral metabolites, and the variations of their concentration to characterize different pathologies. | Other | – |
Primary outcome
assessment of the executive dysfunction
Time frame: one day
NEPSY score <-1 DS is <8 (required) it is a tool to assess the neuropsychological development of children of preschool and school age (3 to 12 years)
intellectual efficiency
Time frame: one day
Wechsler Preschool and Primary Scale of Intelligence (WPPSI)
perceptual organization and memory
Time frame: one day
figure of REY is a short test of perceptual organization and memory. The figure of Rey is called abnormal for a copy <10th percentile.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
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.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
Questions about this trial
What is this clinical trial studying?
An observational study of Children Born Very Prematurely in Relation to Structural Brain Abnormalities, run by Assistance Publique Hopitaux De Marseille.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barthelemy TOSELLO (0645918286, barthelemy.tosello@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the executive dysfunction (time frame: one day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2017.