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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03125447
Other study ID # 2017-A00327-46
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 29, 2017
Est. completion date December 31, 2020

Study information

Verified date February 2023
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Attention functions have a major impact on children's social and school behavior. They are an important issue for prematurely born children often seen as having learning difficulties and being restless, when it could be an adaptative answer to attention disorders. The aim of this study is to evaluate attention capacity in former premature children aged 6-7 years old with regards to different postures or mobility, for the attention functions of orienting, alerting and executive control. The Attention Network Test using reaction time and accuracy to visual stimuli will be used to evaluate attention functions in each posture and mobility.


Description:

Attention functions have a major impact on children's social, school and emotional adjustment. They are one of the most common issues for prematurely born children with implications in academic and social-behavioral functioning. Prematurely born infants are often seen as having excessive mobility or being restless when it could be an adaptative answer to attention disorders leading to learning difficulties. Respecting spontaneous mobility could improve attention performance in vulnerable children. The aim of the study is to evaluate global attention performance of former premature children at the preschool age of 6 to 7 years. This evaluation will be done in three usual postures or mobility, and for the 3 attentional functions of orienting, alerting or executive control. They will be compared within the prematurely born children group and to term born controls of the same age. The Attention Network Test adapted to children by Rueda et al (Neuropsychologia 2004) using reaction time and accuracy to visual stimuli will be used to evaluate attention functions. Presentation of stimuli through virtual video glasses and collection of answers will be done thanks to a specific software.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date December 31, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 8 Years
Eligibility Main Inclusion Criteria: - Children born before 35 weeks gestation and routinely followed for their prematurity in the follow-up clinic of the Maternite Regionale Universitaire Healthy term born children recruited after information leaflet displayed in the University but not the Hospital Main Exclusion Criteria: - Children with a visual or motor disability preventing the realization of the test

Study Design


Related Conditions & MeSH terms


Intervention

Other:
speed and accuracy answer to visual stimuli
A yellow fish swimming over a blue-green background will appear on the screen of virtual glasses. The child will have to give as fast as possible the direction of the fish pushing the left or right button of a computer mouse

Locations

Country Name City State
France Maternity Hospital CHRU Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Rosenbaum J, Ceyte H, Hamon I, Deforge H, Hascoet AMJ, Caudron S, Hascoet JM. Influence of body mobility on attention networks in school-aged prematurely born children: A controlled trial. Front Pediatr. 2022 Sep 8;10:928541. doi: 10.3389/fped.2022.928541 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reaction time to respond to visual stimuli appearance 48 trials of swimming fishes displayed for a maximum of 2500 msec in different conditions: the reaction time in msec will be recorded and evaluated 5 minutes
Secondary Accuracy to the response to visual stimuli direction 48 trials of swimming fishes to the right or the left hand side where the child has to give the right direction of the fish 5 minutes
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