NCT01615523

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 8, 2012

Status Verified

June 1, 2012

Enrollment Period

3.2 years

First QC Date

June 6, 2012

Last Update Submit

June 7, 2012

Conditions

Keywords

Executive functions

Study Arms (2)

Children/adolescents born preterm

Other: MRI, EEG and cognitive testing

Control children and adolescents

Other: MRI, EEG and cognitive testing

Interventions

Sleep EEG and one MRI, executive function testing using Strrop test, BRIEF questionnaire and CantabEclipse

Children/adolescents born pretermControl children and adolescents

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents born preterm with their peers as controls

You may qualify if:

  • 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

You may not qualify if:

  • Preterm Group: MDI \< 85 at 5 years of age; cerebral palsy
  • Control Group: born \<37 weeks of gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Neonatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

Magnetic Resonance SpectroscopyNeuropsychological Tests

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Cornelia F Hagmann, MD

    University Hospital Zurich, Division of Neonatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cornelia Franziska Hagmann, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 8, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 8, 2012

Record last verified: 2012-06

Locations