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

NCT04696679 | Completed

• 2 other identifiers: 2020-382020-A01631-38
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Very Preterm Children With Dysexecutive Disorders

Outcome Measures

Primary Outcomes (2)

• Assessment of the quality of life using the questionnaire Kidscreen 10 Index

  The questionnaire Kidscreen 10 Index was developed in several European countries including France. It comprises 10 items from a version of 27 items, which explore the following domains: physical well-being, psychological well-being (positive and negative), autonomy and parents, peers and social support, and school environment

  1 day

• Assessment of the quality of life using The VSP-A questionnaire (Life and Perceived Health of the Adolescent and the Child)

  The VSP-A questionnaire (Life and Perceived Health of the Adolescent and the Child) which groups together nine dimensions (vitality, psychological well-being, friendships, recreation, family relationships, physical well-being, relationships with teachers, schoolwork, and self-esteem)

  1 day

Secondary Outcomes (3)

• Specific data concerning the period of confinement-deconfinement

  1 day

• Data on children behavioral disorders:

  1 day

• Data concerning the anxiety symptoms of the parent completing the survey questionnaire:

  1 day

Study Arms (2)

Very preterm children group

Other: Patient Quality of life assessment

Control group

Other: Control group Quality of life assessment

Interventions

Patient Quality of life assessment OTHER

Other: Patient questionnaire about quality of life assessment and their determinants during the confinement-deconfinement period of Covid-19 pandemic in France

Very preterm children group

Control group Quality of life assessment OTHER

Other: Patient questionnaire about quality of life assessment and their determinants during the confinement-deconfinement period of Covid-19 pandemic in France relationships with teachers, schoolwork, and self-esteem)

Control group

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged between 7 and 9

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique des Hopitaux de Marseille

Marseille, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: January 6, 2021
• Study Start: June 19, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

FR (1)