Clinical trial NCT04696679: Quality of Life of Very Preterm Children With Dysexecutive Disorders at Elementary School Age During the Confinement-deconfinement Period of Covid-19 Pandemic
Official title: Quality of Life of Very Preterm Children With Dysexecutive Disorders at Elementary School Age During the Confinement-deconfinement Period of Covid-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Very Preterm Children With Dysexecutive Disorders
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 170
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged between 7 and 9

Brief summary: Since March 2020, a new HCoV, SARS-Cov2, originating in China, has been spreading around the world. As of 13 may 2020, almost 4.2 million cases of infections and 292 000 died were reported worldwide (140 000 infection cases and 27 000 died in France). Human coronaviruses (HCoV) usually cause common upper respiratory tract infections in children and sometimes exacerbate lung and asthma diseases.

To minimize the risk of contamination of SARS-Cov2 (Covid-19), the French government has put in place directives that modified the daily lives of students, teachers and families. The societal change imposed by the state of health emergency with a confinement and deconfinement period could strongly impact the quality of life of very preterm children with dysexecutive disorders. These children are a population vulnerable to changes, especially during the pivotal period of elementary school. The executive dysfunctions disrupt children's learning and schooling, as well as their social adaptation, compromising their personal development and therefore, their quality of life.


Eligibility criteria: Very preterm children group :

* Children at elementary school age 7 to 9
* Children included in the cohort of EPIREMED study, born between 24 and 34 weeks' GA (gestational amenorrhea) and having visuospatial Working Memory impairment defined by a working memory index \<85 from the WPPSI IV
* Children able to read, write and comprehend;
* Children whose parents are not opposed to the participation in the study
* Children affiliated to the French social security system

Control group :

* Children at elementary school age 7 to 9
* Children born at full-term and without dysexecutive disorders
* Children from the staff of the Assistance Publique - Hôpitaux de Marseille (AP-HM) / from the staff of the French Mediterranean network (PERINAT-MED) / from the close entourage of EPIREMED children
* Children able to read, write and comprehend
* Children whose parents are not opposed to the participation in the study
* Children affiliated to the French social security system

Primary outcomes:
measure: Assessment of the quality of life using the questionnaire Kidscreen 10 Index
timeFrame: 1 day
measure: Assessment of the quality of life using The VSP-A questionnaire (Life and Perceived Health of the Adolescent and the Child)
timeFrame: 1 day
Secondary outcomes:
measure: Specific data concerning the period of confinement-deconfinement
timeFrame: 1 day
measure: Data on children behavioral disorders:
timeFrame: 1 day
measure: Data concerning the anxiety symptoms of the parent completing the survey questionnaire:
timeFrame: 1 day
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique des Hopitaux de Marseille
Study officials:
References: