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)

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.

Study Overview

• Status: Completed
• Conditions: Very Preterm Children With Dysexecutive Disorders
• Intervention / Treatment: Other: Patient Quality of life assessment; Other: Control group Quality of life assessment

• Study Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Assistance Publique Des Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children aged between 7 and 9

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group	Other: Control group Quality of life assessment; 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)
Very preterm children group	Other: Patient Quality of life assessment; Other: Patient questionnaire about quality of life assessment and their determinants during the confinement-deconfinement period of Covid-19 pandemic in France

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific data concerning the period of confinement-deconfinement	continuation of parental employment and current modalities: face-to-face, teleworking, part-time employment, etc.; possible schooling and current modalities: continued schooling, interruption of schooling, etc.; related ad hoc items to the state of health of the family unit, to medical events that have occurred (including family member(s) with a Covid-19 infection), to a history of hospitalization related to Covid-19 reasons, (reasons, consequences, frequency) between the beginning of the confinement and the moment they complete the questionnaire; as well as ad hoc items of anxiety related to Covid-19	1 day
Data on children behavioral disorders:	assessed by the Goodman questionnaire (Strengths and Difficulties Questionnaire)	1 day
Data concerning the anxiety symptoms of the parent completing the survey questionnaire:	assessed by the Spielberger questionnaire, as a personality trait and as an emotional state linked to the health protocol (State-Trait Anxiety Inventory, STAI)	1 day

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; COVID-19; Premature Birth
• Other Study ID Numbers: 2020-38; 2020-A01631-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No