Cognitive and Postural Activities of Prematurely Born Children

NCT04275895 | Completed

• 1 other identifier: 2019-A02385-52
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Prematurely born children (PC) have academic difficulties related to poorer attention capabilities. Additionally, they often show excessive mobility, quoted as agitation. Some consider it could be related to poorer postural control and impaired perception of gravity vertical. But, this excessive mobility could also be an unconscious way for PC to improve their attention performance. The aim of this study is to evaluate the interdependence between postural and cognitive activities in school age PC versus term born children (TC). First, the performance of PC and TC at the Attention Network Test for Children will be analyzed with the use of a mobile versus a classic school chair. Secondly, participants will have to position a stick vertically to measure their perception of vertical gravity. Finally, the spontaneous postural activity of PC and TC (evaluated by the center of pressure displacement) will be studied during the execution of three different attention tasks at different levels of difficulty. Success rate and reaction time will be analyzed for all attention tasks. Moreover, center of pressure displacement calculation will allow evaluation of infants' spontaneous mobility, the precision of their postural control and the attention allocated to their posture.

Conditions

Attention Deficit; Mobility; Postural Activity

Keywords

Prematurely born children; Attention function; Posture; Mobility

Outcome Measures

Primary Outcomes (4)

• Accuracy and Reaction time (in msec) to the response to visual target (fish) direction

  40 trials of fishes displayed for a maximum of 2500 msec to the left or the right hand side, by chair condition (classic, mobile), where the child has to give as quickly as possible the direction of the fish

  8 minutes

• Angle error (in degree) between the stick orientation given by the child and the real vertical

  3 trials of randomly inclined stick by position (sitting, lying to the right, lying to the left) where the child has to turn the stick vertically

  4 minutes 30 secondes

• Sway path (distance traveled by the center of pressure - CP -) and surface area (ellipse covering 90% of the center of pressure displacement)

  3 x 30 secondes of record on the force plate by standing condition (eyes opened watching a cartoon, gazing a fixation cross, eyes closed) where the child has to stay up without move their feet

  4 minutes 30 secondes

• Sway path (distance traveled by the center of pressure - CP -), surface area (ellipse covering 90% of the center of pressure displacement) and entropy (index of regularity of postural oscillations)

  2 x 1 minutes of record on the force plate by level of difficulty (easy, difficult) and by task (vigilance task, visual search task, inhibition task)

  12 minutes

Study Arms (2)

Prematurely born Children

EXPERIMENTAL

Evaluation of different attention or/and postural activities : 1. Speed and accuracy answer to visual fish (target) appearance evaluated in two conditions of chair (mobile or classic). 2. Child perception of the vertical compared to the real vertical 3. Evaluation of the posture of the child during different visual conditions 4. Evaluation of the posture of the child during different attention tasks at different levels of difficulty

Behavioral: Evaluation of different attention or/and postural activities

Term born Children

ACTIVE COMPARATOR

Evaluation of different attention or/and postural activities 1. Speed and accuracy answer to visual fish (target) appearance evaluated in two conditions of chair (mobile or classic). 2. Child perception of the vertical compared to the real vertical 3. Evaluation of the posture of the child during different visual conditions 4. Evaluation of the posture of the child during different attention tasks at different levels of difficulty

Behavioral: Evaluation of different attention or/and postural activities

Interventions

Evaluation of different attention or/and postural activities BEHAVIORAL

1. The children, equipped with a head-mounted display (HMD), will indicate as quickly as possible the direction of a fish that can be surrounded by congruent or not flankers (Inhibition) and/or preceded by signal (Alert) 2. The children, equipped with a HMD and a joystick, will vertically turn a randomly inclined stick 3. The children will stand on a force plate watching a cartoon, gazing a fixation cross or eyes closed 4. The children, equipped with an augmented reality headset, will perform 2 levels of difficulty of 3 attention tasks standing on a force plate: * They will click as quickly as possible when they see a frog among successively appearing animals (vigilance task) * They will give the name of an animal appearing at one of the windows displayed (visual search task) * They will count the number of yellow lions oriented to the right among several animals of different color and direction (inhibition task) 5. Growth trajectory will be retrieved from health booklet

Prematurely born Children; Term born Children

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children born before 37 weeks gestation or at term and routinely followed for their prematurity in the follow-up clinic of the Maternite Regionale Universitaire and healthy term born children recruited after information in different schools of Meurthe-et-Moselle
• Child whose holders of parental authority have received complete information on the organization of the research and have signed the consent

You may not qualify if:

• Severe hypotrophy at birth defined by a weight z-score below -2.
• Children with developmental, cognitive, visual or motor disability preventing the execution of the tests

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Maternite Regionale Universitaire CHRU NANCY

Nancy, Lorraine, 54035, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor ; principal investigator

Model Details: Attention performance of a group of prematurely born children will be compared on a classical school chair and a mobile school chair. The same comparison will be made for a group of term born children. The perception of the Vertical gravity of the two groups will be evaluated in sitting position, lying to the right side and lying the left side. The postural control of the two groups will be evaluated standing on a force plate in three conditions : eyes opened watching a cartoon, eyes opened gazing a fixation cross on the wall and eyes closed. The postural control of the two groups will be measured during the execution of three different attentional tasks. For each task, two levels of difficulty will be tested. Finally, growth trajectory from birth will be analysed as a confounding factor.

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: September 11, 2020
• Primary Completion: December 30, 2023
• Study Completion: August 15, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)