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

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

      • Nancy, France, 54035
        • Maternity Hospital CHRU

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.

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.

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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