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Quality of Life of Very Preterm Children With Dysexecutive Disorders at Elementary School Age During the Confinement-deconfinement Period of Covid-19 Pandemic (GPE-QolVID)

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Very Preterm Children With Dysexecutive Disorders

Treatments

Other: Patient Quality of life assessment
Other: Control group Quality of life assessment

Study type

Observational

Funder types

Other

Identifiers

NCT04696679
2020-38
2020-A01631-38 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

170 patients

Sex

All

Ages

7 to 9 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

170 participants in 2 patient groups

Very preterm children group
Treatment:
Other: Patient Quality of life assessment
Control group
Treatment:
Other: Control group Quality of life assessment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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