NCT03125447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 29, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

2.6 years

First QC Date

April 14, 2017

Last Update Submit

February 13, 2023

Conditions

Keywords

Prematurely born childrenAttention functionPostureMobility

Outcome Measures

Primary Outcomes (1)

  • 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

    5 minutes

Secondary Outcomes (1)

  • Accuracy to the response to visual stimuli direction

    5 minutes

Study Arms (2)

Prematurely born children

EXPERIMENTAL

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

Other: speed and accuracy answer to visual stimuli

Term born children

ACTIVE COMPARATOR

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

Other: speed and accuracy answer to visual stimuli

Interventions

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

Prematurely born childrenTerm born children

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Children with a visual or motor disability preventing the realization of the test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity Hospital CHRU

Nancy, 54035, France

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Mobility Limitation

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Design

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

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 24, 2017

Study Start

May 29, 2017

Primary Completion

December 30, 2019

Study Completion

December 31, 2020

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations