Mobility and Attention Capacity in Former Premature Children

NCT ID: NCT03125447

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-29

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Attention Concentration Difficulty Mobility Limitation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

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
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Prematurely born children

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

Group Type EXPERIMENTAL

speed and accuracy answer to visual stimuli

Intervention Type 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

Term born children

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

Group Type ACTIVE_COMPARATOR

speed and accuracy answer to visual stimuli

Intervention Type 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

Interventions

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speed and accuracy answer to visual stimuli

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

Intervention Type OTHER

Eligibility Criteria

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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

Exclusion Criteria

* Children with a visual or motor disability preventing the realization of the test
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Jean-Michel HASCOET

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maternity Hospital CHRU

Nancy, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 36160773 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30081860 (View on PubMed)

Other Identifiers

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2017-A00327-46

Identifier Type: -

Identifier Source: org_study_id

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