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Completed

NCT Number: NCT03125447

Mobility and Attention Capacity in Former Premature Children

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.

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Key information

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternity Hospital CHRU

Nancy, 54035, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

speed and accuracy answer to visual stimuli

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Posture and Mobility Influence on Attention Capacity in Former Premature Children at 6 Years of Age.

Acronym: PAM

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Apr 24, 2017
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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