Premature Baby 25 to 32 WeeksEPIRMEXNCT02083822
Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions
A study testing term MRI, executive EF functions testing in people with Premature Baby 25 to 32 Weeks, run by University Hospital, Tours at 15 sites in France.
Trial summary
The survival of premature babies increased during the last decades. However, the neurocognitive long term development of these children is worrying, as demonstrated by EPIPAGE 1 study. Read more about this study
- Who is it for?
- Ages 25 to 32 weeks
- Conditions the study is for
- Premature Baby 25 to 32 Weeks
- What is being tested?
- term MRI, executive EF functions testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 15 sitesFrance
- Study dates
- 30 Jun 2011to 8 Jan 2018
- 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 25 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants who were :
- born between 25 and 32 WGA
- hospitalized in a neonatology service which participate to the present study
- included in EPIPAGE 2 follow-up study
- infants whose parents had signed the consent agreement and benefit from national health insurance
Who cannot join
- Infants with congenital abnormalities
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Service de Neurologie Pédiatrique
Angers, 49 000
Service de Néonatologie
Bordeaux, 33 000
Service de Néonatologie
Caen, 14 000
Médecine Néonatale et Réanimation Pédiatrique
Grenoble, 38 000
Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE
Le Kremlin-Bicêtre, 94275
Service de Néonatologie
Lille, 59 000
Médecine Infantile - Néonatologie - Périnatologie
Marseille, 13 000
Service de Néonatalogie
Marseille, 13 000
Service de Néonatologie
Nancy, 54000
Service de Néonatologie
Nantes, 44000
Réanimation néonatale et Néonatologie
Paris, 75 000
Service de Réanimation, Néonatologie
Reims, 51 000
Service de Néonatologie
Rennes, 35000
Service de Pédiatrie Néonatale et Réanimation
Rouen, 76000
Service de Réanimation pédiatrique, Néonatologie
Tours, 37 000
About this study
The survival of premature babies increased during the last decades. However, the neurocognitive long term development of these children is worrying, as demonstrated by EPIPAGE 1 study.
These children present high risk of deficits such as cognitive deficits, adaptive malfunction, behavior disorders and difficulties in school learning.
Read more
Understanding the specific neuropsychological disorders at the origin of these deficits is an important objective. Studies realized at school age showed that many premature children have executive functions (EF) disorders. However the specific nature of these disorders and the neuropathology associated are unknown.
The aim of this study is to realise MRI at term age in preterm babies born less than 32 GA and to correlate MRI findings with executives functions and neurodevelopmental outcome
Read the detailed description
An MRI would be realized between 39 and 41 GA
At the age of 5 years, executive functions and neurodevelopmental testing would be realized.
600 newborns were recruited.
- Conditions
- Premature Baby 25 to 32 Weeks
- Being tested
- term MRI, executive EF functions testing
- Keywords
- premature baby, MRI : conventional and advanced images, Executive function testing at 5 years of age
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
term MRI, executive EF functions testingProcedure or surgery
An MRI will be realized at term born between 25 and 32 weeks GA
| Study group | Role | What they receive |
|---|---|---|
| MRI assessment | Experimental | Not described Receives: Procedure: term MRI, executive EF functions testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings
Measured: During the 5 years follow up
Secondary outcomes (2)
Perinatal risk factors and cerebral lesions as assessed on MRI
Measured: During the 5 years follow up
Perinatal risk factors and executive and cognitive functions evaluated at 5 years of age
Measured: During the 5 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study start30 Jun 2011
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Baby 25 to 32 WeeksStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083822
- Sponsor's protocol ID
- PHRN11-ES / EPIRMEX
- Acronym
- EPIRMEX
- Status last verified
- Jun 2026
- First submitted
- 13 Dec 2013
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions
- ClinicalTrials.gov ID
- NCT02083822
- Acronym / sponsor ID
- EPIRMEX / PHRN11-ES / EPIRMEX
- Conditions
- Premature Baby 25 to 32 Weeks
- Keywords
- premature baby, MRI : conventional and advanced images, Executive function testing at 5 years of age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 30 Jun 2011 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 11 Mar 2014 (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 survival of premature babies increased during the last decades. However, the neurocognitive long term development of these children is worrying, as demonstrated by EPIPAGE 1 study.
These children present high risk of deficits such as cognitive deficits, adaptive malfunction, behavior disorders and difficulties in school learning.
Understanding the specific neuropsychological disorders at the origin of these deficits is an important objective. Studies realized at school age showed that many premature children have executive functions (EF) disorders. However the specific nature of these disorders and the neuropathology associated are unknown.
The aim of this study is to realise MRI at term age in preterm babies born less than 32 GA and to correlate MRI findings with executives functions and neurodevelopmental outcome
Detailed description
An MRI would be realized between 39 and 41 GA
At the age of 5 years, executive functions and neurodevelopmental testing would be realized.
600 newborns were recruited.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI assessment | Experimental | Procedure: term MRI, executive EF functions testing |
Who may qualify
- Ages
- 25 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- born between 25 and 32 WGA
- hospitalized in a neonatology service which participate to the present study
- included in EPIPAGE 2 follow-up study
- infants whose parents had signed the consent agreement and benefit from national health insurance
Key exclusion criteria (1 listed)
- Infants with congenital abnormalities
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 |
|---|---|---|
| term MRI, executive EF functions testingAn MRI will be realized at term born between 25 and 32 weeks GA | Procedure or surgery | MRI assessment |
Primary outcome
Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings
Time frame: During the 5 years follow up
2 secondary outcomes
Perinatal risk factors and cerebral lesions as assessed on MRI
Time frame: During the 5 years follow up
Perinatal risk factors and executive and cognitive functions evaluated at 5 years of age
Time frame: During the 5 years follow up
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 17 Jun 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing term MRI, executive EF functions testing in people with Premature Baby 25 to 32 Weeks, run by University Hospital, Tours at 15 sites 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 1 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 17 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 15 sites 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?
Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings (time frame: During the 5 years follow up). 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 17 Jun 2026.