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Mobility and Attention Capacity in Former Premature Children (PAM)

Primary Purpose

Attention Concentration Difficulty, Mobility Limitation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
speed and accuracy answer to visual stimuli
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Attention Concentration Difficulty focused on measuring Prematurely born children, Attention function, Posture, Mobility

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maternity Hospital CHRU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prematurely born children

Term born children

Arm Description

Speed and accuracy answer to visual stimuli evaluated in 3 distinct posture/mobility situations

Speed and accuracy answer to visual stimuli evaluated in 3 distinct posture/mobility situations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 14, 2017
Last Updated
February 13, 2023
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03125447
Brief Title
Mobility and Attention Capacity in Former Premature Children
Acronym
PAM
Official Title
Posture and Mobility Influence on Attention Capacity in Former Premature Children at 6 Years of Age.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 29, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Concentration Difficulty, Mobility Limitation
Keywords
Prematurely born children, Attention function, Posture, Mobility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Attention capacity will be compared in three situations of posture/mobility in a group of prematurely born children, and compared to the same situations in a group of term born children
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prematurely born children
Arm Type
Experimental
Arm Description
Speed and accuracy answer to visual stimuli evaluated in 3 distinct posture/mobility situations
Arm Title
Term born children
Arm Type
Active Comparator
Arm Description
Speed and accuracy answer to visual stimuli evaluated in 3 distinct posture/mobility situations
Intervention Type
Other
Intervention Name(s)
speed and accuracy answer to visual stimuli
Intervention Description
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 Outcome Measure Information:
Title
Reaction time to respond to visual stimuli appearance
Description
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
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Accuracy to the response to visual stimuli direction
Description
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
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Maternity Hospital CHRU
City
Nancy
ZIP/Postal Code
54035
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36160773
Citation
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.
Results Reference
result
PubMed Identifier
30081860
Citation
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.
Results Reference
derived

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Mobility and Attention Capacity in Former Premature Children

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