NCT04548245

Brief Summary

This project aims to identify precursors of executive attention that can serve as early markers of ADD.

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
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

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

August 31, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

February 13, 2023

Status Verified

March 1, 2022

Enrollment Period

2.7 years

First QC Date

August 31, 2020

Last Update Submit

February 10, 2023

Conditions

Attention Deficit Disorder

Outcome Measures

Primary Outcomes (1)

  • Amplitude in µV of EEG changes relative to baseline when expected stimulus is omitted in a tactile stimulation sequence

    at 4 years old

Study Arms (2)

Term

Device: EEG

Preterm

Device: EEG

Interventions

EEGDEVICE

EEG

PretermTerm

Eligibility Criteria

Age48 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preschool children born preterm vs term

You may qualify if:

  • Normal schooling
  • Parental consent

You may not qualify if:

  • \- Psychotropic drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comete U1075 Inserm Unicaen

Caen, 14032, France

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Central Study Contacts

Nadege Roche-Labarbe, PhD

CONTACT

+33(0)649922568nadege.roche@unicaen.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 14, 2020

Study Start

February 1, 2021

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

February 13, 2023

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)