- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03125447
Mobility and Attention Capacity in Former Premature Children (PAM)
February 13, 2023 updated by: Jean-Michel HASCOET, Central Hospital, Nancy, France
Posture and Mobility Influence on Attention Capacity in Former Premature Children at 6 Years of Age.
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nancy, France, 54035
- Maternity Hospital CHRU
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 8 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prematurely born children
Speed and accuracy answer to visual stimuli evaluated in 3 distinct posture/mobility situations
|
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
|
Active Comparator: Term born children
Speed and accuracy answer to visual stimuli evaluated in 3 distinct posture/mobility situations
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaction time to respond to visual stimuli appearance
Time Frame: 5 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy to the response to visual stimuli direction
Time Frame: 5 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. eCollection 2022.
- Ceyte H, Rosenbaum J, Hamon I, Wirth M, Caudron S, Hascoet JM. Mobility may impact attention abilities in healthy term or prematurely born children at 7-years of age: protocol for an intervention controlled trial. BMC Pediatr. 2018 Aug 6;18(1):264. doi: 10.1186/s12887-018-1229-1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 29, 2017
Primary Completion (Actual)
December 30, 2019
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
April 14, 2017
First Submitted That Met QC Criteria
April 19, 2017
First Posted (Actual)
April 24, 2017
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-A00327-46
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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