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NCT04696679: GPE-QolVID

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

Completed Last updated 29 January 2021
What this trial tests

trial testing Patient Quality of life assessment in Very Preterm Children With Dysexecutive Disorders in 170 participants. Completed in 31 December 2020.

Timeline
19 June 2020
Primary endpoint
30 November 2020
31 December 2020

Quick facts

Lead sponsorAssistance Publique Hopitaux De Marseille
StatusCompleted
Study typeOBSERVATIONAL
Enrollment170
Start date19 June 2020
Primary completion30 November 2020
Estimated completion31 December 2020
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

Adults 7 to 9, any sex, with Very Preterm Children With Dysexecutive Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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