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

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Completed
CT.gov ID
NCT04696679
Collaborator
(none)
170
1
6.4
26.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patient Quality of life assessment
  • Other: Control group Quality of life assessment

Study Design

Study Type:
Observational
Actual Enrollment :
170 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
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
Actual Study Start Date :
Jun 19, 2020
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
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

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)

Outcome Measures

Primary Outcome Measures

  1. Assessment of the quality of life using the questionnaire Kidscreen 10 Index [1 day]

    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

  2. Assessment of the quality of life using The VSP-A questionnaire (Life and Perceived Health of the Adolescent and the Child) [1 day]

    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)

Secondary Outcome Measures

  1. Specific data concerning the period of confinement-deconfinement [1 day]

    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

  2. Data on children behavioral disorders: [1 day]

    assessed by the Goodman questionnaire (Strengths and Difficulties Questionnaire)

  3. Data concerning the anxiety symptoms of the parent completing the survey questionnaire: [1 day]

    assessed by the Spielberger questionnaire, as a personality trait and as an emotional state linked to the health protocol (State-Trait Anxiety Inventory, STAI)

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 9 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assistance Publique des Hopitaux de Marseille Marseille France

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT04696679
Other Study ID Numbers:
  • 2020-38
  • 2020-A01631-38
First Posted:
Jan 6, 2021
Last Update Posted:
Jan 29, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 29, 2021