Children Born Extremely PrematureEPIREMEDNCT02757794
Long-term Effects of Visual Spatial Working Memory Training Program Performed at Preschool Age in Very Preterm Infants With Visual Spatial Working Memory Deficit. A Randomized Controlled Trial
A study testing computerized cognitive remediation program and standard remediation in people with Children Born Extremely Premature and Disturbance of Visuo-spatial Working Memory, run by Assistance Publique Hopitaux De Marseille at 18 sites in France.
Trial summary
Prematurity tends to increase in France in recent years and more children born extremely premature infants survive. If severe impairments have stabilized, the majority of former extremely premature children have neuropsychological disorders and moderate appearance behavior disorder, but with a significant impact both… Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Children Born Extremely Premature, Disturbance of Visuo-spatial Working Memory
- What is being tested?
- computerized cognitive remediation program and standard remediation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 18 sitesFrance
- Study dates
- 29 Nov 2016to 20 Aug 2019
- 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 5 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Already included in the study EPIPAGE 2, born between 24 and 34 weeks' GA (gestational amenorrhea),
- Children aged 5 to 6 years,
- Children exhibiting a total intellectual quotient >70 from the WPPSI IV (during the 5-year assessment in EPIPAGE 2),
- Children having a visuo-spatial Working Memory impairment defined by a working memory index <85 from the WPPSI IV,
- Children with parents (or legal guardians) authorizing participation in the study and a signed informed consent form,
- Children affiliated with medical insurance.
Who cannot join
- Children with severe cerebral palsy, based on the Gross Motor Function (GMFCS score >2) and Bimanual Fine Motor Function (BFMF >2) classification system (Elvrum AG 2015, Marois P 2015),
- Children with blindness or amblyopia, defined by a visual acuity <3 (during the 5-year assessment in EPIPAGE 2),
- Children with deafness, as defined by a prescribed hearing aid,
- Children with chromosomal disorder or autistic syndrome,
- Children included in the EPILANG study protocol (an ancillary project to EPIPAGE),
- Children who do not speak French
- Children with parents having no internet connection,
- Triplets.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
University Hospital of Lyon
Bron, 69677
University Hospital of Caen Normandie
Caen, 14033
University Hospital of Clermont-Ferrand
Clermont-Ferrand, 63003
Sud Francilien Hospital
Corbeil-Essonnes, 91 106
University Hospital of Grenoble
Grenoble, 38 043
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
University Hospital of Montpellier
Montpellier, 34295
Regional University Hospital of Nancy
Nancy, 54035
University Hospital of Nantes
Nantes, 44093
University Hospital of Nice
Nice, 06300
University Hospital of Nîmes
Nîmes, 30029
AP- HP - Armand Trousseau Hospital
Paris, 75012
University Hospital of Reims
Reims, 51092
University Hospital of Rouen
Rouen, 76031
University Hospital of Saint-Etienne
Saint-Etienne, 42055
Regional University Hospital of Strasbourg
Strasbourg, 67200
University Hospital of Toulouse
Toulouse, 31059
University Hospital of Tour
Tours, 37000
About this study
Prematurity tends to increase in France in recent years and more children born extremely premature infants survive. If severe impairments have stabilized, the majority of former extremely premature children have neuropsychological disorders and moderate appearance behavior disorder, but with a significant impact both family, school and social persisting into adulthood.
Executive functions (EF), in general, and working memory (MT), in particular, are frequently altered in older children preterm infants compared to controls born at term.
Read more
The identification process of loss in certain diseases, as well as improving knowledge of brain functioning, and development with the possibility of neuronal plasticity has led research teams to develop intervention programs focused on process cognitive qualified of "remediation" cognitive (RC). Schematically, the RC is defined as a rehabilitation or altered cognitive functions. MT can be improved by encouraging the operation of the spots mental stimulant. These programs are effective on MT but do not have the expected impact on other FE, language or nonverbal functions (visuospatial). The functional benefit of cognitive remediation remains controversial.
Improving mental functions untrained as nonverbal MT, attention and secondarily learning is possible but still unproven on wide population. Similarly, randomized trials are needed to test this type of cognitive remediation among preschoolers old very premature.
- Being tested
- computerized cognitive remediation program, standard remediation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized cognitive remediation programOther
a computer program online re-educating the working memory is completed by the parents and the child. The child made a series of interactive exercises accompanied by parents or a practitioner. The exercises are adapted automatically and individually to the performance at each session.
standard remediationOther
A speech therapy and / or academic support is realized.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive remediation parents | Active comparator | Not described Receives: Other: computerized cognitive remediation program |
| Remediation standard | Placebo comparator | Not described Receives: Other: standard remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of the measuring index visuospatial
This index consists of two subtests : block design and object assembly. The average score is 100 with a standard deviation of 15.
Measured: 18 months (more or less 2 months) post inclusion
Secondary outcomes (8)
Assessment of intellectual functioning
award of global IQ
Measured: 8 months (more or less 2 months) post inclusion
Evaluation of the working memory
administering the questionnaire Wechsler Preschool and Primary Scale of Intelligence (WPPSI IV)
Measured: 18 months (more or less 2 months) post inclusion
evaluation of neuropsychological development of children
award of Neuropsychological Assessment test (NEPSY)
Measured: 8 months (more or less 2 months) post inclusion
Evaluation of language and skills
passing the test Communicate, Learn to Read and Write (KEY)
Measured: 8 months (more or less 2 months) post inclusion
Rating behavior
award of Goodman questionnaire (Strengths and Difficulties Questionnaire (SDQ))
Measured: 8 months (more or less 2 months) post inclusion
Evaluation of parental anxiety
award of Spielberger Trait Anxiety Inventory questionnaire
Measured: 8 months (more or less 2 months) post inclusion
Assessing the quality of a child's life
Quality of Life Questionnaire
Measured: 8 months (more or less 2 months) post inclusion
Evaluation of Education
Evaluation of Education is evaluated by the global adaptation school score (GSA) survey
Measured: 8 months (more or less 2 months) post inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start29 Nov 2016
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Children Born Extremely PrematureStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757794
- Sponsor's protocol ID
- 2016-01
- Other IDs
- 2016-A00122-49, RCAPHM16_0010
- Acronym
- EPIREMED
- Status last verified
- Jul 2023
- First submitted
- 28 Apr 2016
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Gire C, Beltran Anzola A, Marret S, Foix L'Helias L, Roze JC, Granier M, Patural H, Lecomte B, Guillois B, Souksi Medioni I, Bednarek Weirauch N, Claris O, Hascoet JM, Kuhn P, Zahed M, Boucekine M, Ancel PY, Arnaud C, Cambonie G, Dorriere Datin V; EPIREMED Study Group. Cognitive Training for Visuospatial Processing in Children Aged 5(1/2) to 6 Years Born Very Preterm With Working Memory Dysfunction: A Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2331988. doi: 10.1001/jamanetworkopen.2023.31988.
PubMed 37676661Gire C, Beltran Anzola A, Kaminski M, Baumstarck K, Ancel PY, Berbis J; for EPIREMED-Study Group. A randomized EPIREMED protocol study on the long-term visuo spatial effects of very preterm children with a working memory deficit. BMC Pediatr. 2021 Sep 13;21(1):402. doi: 10.1186/s12887-021-02867-x.
PubMed 34517869
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Visual Spatial Working Memory Training Program Performed at Preschool Age in Very Preterm Infants With Visual Spatial Working Memory Deficit. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02757794
- Acronym / sponsor ID
- EPIREMED / 2016-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 2 May 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.
Prematurity tends to increase in France in recent years and more children born extremely premature infants survive. If severe impairments have stabilized, the majority of former extremely premature children have neuropsychological disorders and moderate appearance behavior disorder, but with a significant impact both family, school and social persisting into adulthood.
Executive functions (EF), in general, and working memory (MT), in particular, are frequently altered in older children preterm infants compared to controls born at term.
The identification process of loss in certain diseases, as well as improving knowledge of brain functioning, and development with the possibility of neuronal plasticity has led research teams to develop intervention programs focused on process cognitive qualified of "remediation" cognitive (RC). Schematically, the RC is defined as a rehabilitation or altered cognitive functions. MT can be improved by encouraging the operation of the spots mental stimulant. These programs are effective on MT but do not have the expected impact on other FE, language or nonverbal functions (visuospatial). The functional benefit of cognitive remediation remains controversial.
Improving mental functions untrained as nonverbal MT, attention and secondarily learning is possible but still unproven on wide population. Similarly, randomized trials are needed to test this type of cognitive remediation among preschoolers old very premature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive remediation parents | Active comparator | Other: computerized cognitive remediation program |
| Remediation standard | Placebo comparator | Other: standard remediation |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Already included in the study EPIPAGE 2, born between 24 and 34 weeks' GA (gestational amenorrhea),
- Children aged 5 to 6 years,
- Children exhibiting a total intellectual quotient >70 from the WPPSI IV (during the 5-year assessment in EPIPAGE 2),
- Children having a visuo-spatial Working Memory impairment defined by a working memory index <85 from the WPPSI IV,
- Children with parents (or legal guardians) authorizing participation in the study and a signed informed consent form,
Key exclusion criteria (8 listed)
- Children with severe cerebral palsy, based on the Gross Motor Function (GMFCS score >2) and Bimanual Fine Motor Function (BFMF >2) classification system (Elvrum AG 2015, Marois P 2015),
- Children with blindness or amblyopia, defined by a visual acuity <3 (during the 5-year assessment in EPIPAGE 2),
- Children with deafness, as defined by a prescribed hearing aid,
- Children with chromosomal disorder or autistic syndrome,
- Children included in the EPILANG study protocol (an ancillary project to EPIPAGE),
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 |
|---|---|---|
| computerized cognitive remediation programa computer program online re-educating the working memory is completed by the parents and the child. The child made a series of interactive exercises accompanied by parents or a practitioner. The exercises are adapted automatically and individually to the performance at each session. | Other | Cognitive remediation parents |
| standard remediationA speech therapy and / or academic support is realized. | Other | Remediation standard |
Primary outcome
Increase of the measuring index visuospatial
Time frame: 18 months (more or less 2 months) post inclusion
This index consists of two subtests : block design and object assembly. The average score is 100 with a standard deviation of 15.
8 secondary outcomes
Assessment of intellectual functioning
Time frame: 8 months (more or less 2 months) post inclusion
Evaluation of the working memory
Time frame: 18 months (more or less 2 months) post inclusion
evaluation of neuropsychological development of children
Time frame: 8 months (more or less 2 months) post inclusion
Evaluation of language and skills
Time frame: 8 months (more or less 2 months) post inclusion
Rating behavior
Time frame: 8 months (more or less 2 months) post inclusion
Evaluation of parental anxiety
Time frame: 8 months (more or less 2 months) post inclusion
Assessing the quality of a child's life
Time frame: 8 months (more or less 2 months) post inclusion
Evaluation of Education
Time frame: 8 months (more or less 2 months) post inclusion
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 6 Jul 2023.
- Derived from this study: PubMed 37676661Gire C, Beltran Anzola A, Marret S, Foix L'Helias L, Roze JC, Granier M, Patural H, Lecomte B, Guillois B, Souksi Medioni I, Bednarek Weirauch N, Claris O, Hascoet JM, Kuhn P, Zahed M, Boucekine M, Ancel PY, Arnaud C, Cambonie G, Dorriere Datin V; EPIREMED Study Group. Cognitive Training for Visuospatial Processing in Children Aged 5(1/2) to 6 Years Born Very Preterm With Working Memory Dysfunction: A Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2331988. doi: 10.1001/jamanetworkopen.2023.31988.
- Derived from this study: PubMed 34517869Gire C, Beltran Anzola A, Kaminski M, Baumstarck K, Ancel PY, Berbis J; for EPIREMED-Study Group. A randomized EPIREMED protocol study on the long-term visuo spatial effects of very preterm children with a working memory deficit. BMC Pediatr. 2021 Sep 13;21(1):402. doi: 10.1186/s12887-021-02867-x.
- Individual participant dataSharing planned: Undecided
Related trials for Children Born Extremely Premature
RecruitingObservational study
Assessing Intellectual and Motor Outcomes in High-risk Infants
Cerebral Palsy, Cerebral Palsy (CP)
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, Director study director
Assistance Publique Hôpitaux de Marseille
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computerized cognitive remediation program and standard remediation in people with Children Born Extremely Premature and Disturbance of Visuo-spatial Working Memory, run by Assistance Publique Hopitaux De Marseille at 18 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 6 inclusion and 8 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 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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. Some participants in this study may receive a placebo. 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?
Increase of the measuring index visuospatial (time frame: 18 months (more or less 2 months) post inclusion). 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 NCT02757794, which also lists 2 linked publications.
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 6 Jul 2023.