Preterm InfantsNCT01615523
Executive Function in Preterm Born Children: An Integrative Approach From Genetics to Brain Function
An observational study of Preterm Infants, run by University of Zurich at 1 site in Switzerland.
Trial summary
Hd-EEG and MRI measures are used to study the maturation of functional networks in order to identify the neural circuits underlying executive and memory processes in children born preterm. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Infants
- What is being tested?
- MRI, EEG and cognitive testing
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2012to Dec 2015
- 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children and adolescents born preterm with their peers as controls
Who may be able to join
- Schoolchildren between 10 and 12 or 14 and 16 (born between 1996 and 1998 or between 2000 and 2002)
- Preterm group: born <32 weeks of gestation
- Control group: siblings or friends of preterm group in one of the two age groups
Who cannot join
- Preterm Group: MDI < 85 at 5 years of age; cerebral palsy
- Control Group: born <37 weeks of gestation
Trial locations and contacts
1 site in 1 country.
Cornelia Franziska Hagmann, MD contact
Switzerland1 site
University Hospital Zurich, Division of Neonatology
Zurich, Canton of Zurich, 8091
About this study
Hd-EEG and MRI measures are used to study the maturation of functional networks in order to identify the neural circuits underlying executive and memory processes in children born preterm. It will be determined whether children born preterm with executive function deficits will have an abnormal connectivity between basal ganglia and cortex due to WM injury. Moreover, the development of hd-EEG activity during sleep (coherence and travelling waves) and brain maturation of children and adolescents born preterm will be compared with the respective measures in healthy controls. This is of eminent importance as it helps to understand the nature of executive function and hence, it may help to develop neuroprotective strategies to prevent executive function deficits in these infants.
- Conditions
- Preterm Infants
- Being tested
- MRI, EEG and cognitive testing
- Keywords
- Executive functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI, EEG and cognitive testingOther
Sleep EEG and one MRI, executive function testing using Strrop test, BRIEF questionnaire and CantabEclipse
| Study group | Role | What they receive |
|---|---|---|
| Children/adolescents born preterm | Not described Receives: Other: MRI, EEG and cognitive testing | |
| Control children and adolescents | Not described Receives: Other: MRI, EEG and cognitive testing |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cornelia F Hagmann, MD, Principal investigator, University Hospital Zurich, Division of Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615523
- Sponsor's protocol ID
- EF_MRI_EEG
- Status last verified
- Jun 2012
- First submitted
- 6 Jun 2012
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Function in Preterm Born Children: An Integrative Approach From Genetics to Brain Function
- ClinicalTrials.gov ID
- NCT01615523
- Acronym / sponsor ID
- EF_MRI_EEG
- Conditions
- Preterm Infants
- Keywords
- Executive functions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 Jun 2012 (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.
Hd-EEG and MRI measures are used to study the maturation of functional networks in order to identify the neural circuits underlying executive and memory processes in children born preterm. It will be determined whether children born preterm with executive function deficits will have an abnormal connectivity between basal ganglia and cortex due to WM injury. Moreover, the development of hd-EEG activity during sleep (coherence and travelling waves) and brain maturation of children and adolescents born preterm will be compared with the respective measures in healthy controls. This is of eminent importance as it helps to understand the nature of executive function and hence, it may help to develop neuroprotective strategies to prevent executive function deficits in these infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children/adolescents born preterm | – | Other: MRI, EEG and cognitive testing |
| Control children and adolescents | – | Other: MRI, EEG and cognitive testing |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children and adolescents born preterm with their peers as controls
Key inclusion criteria (3 listed)
- Schoolchildren between 10 and 12 or 14 and 16 (born between 1996 and 1998 or between 2000 and 2002)
- Preterm group: born <32 weeks of gestation
- Control group: siblings or friends of preterm group in one of the two age groups
Key exclusion criteria (2 listed)
- Preterm Group: MDI < 85 at 5 years of age; cerebral palsy
- Control Group: born <37 weeks of gestation
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 |
|---|---|---|
| MRI, EEG and cognitive testingSleep EEG and one MRI, executive function testing using Strrop test, BRIEF questionnaire and CantabEclipse | Other | Children/adolescents born preterm, Control children and adolescents |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.
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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.
Cornelia Franziska Hagmann, MD contact
Cornelia F Hagmann, MD principal investigator
University Hospital Zurich, Division of Neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infants, run by University of Zurich at 1 site in Switzerland.
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 3 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 Jun 2012. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cornelia Franziska Hagmann, MD (cornelia.hagmann@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 Jun 2012.