Neuropsychological Development and Functional Outcome Sin Children With Hirschsprung Disease at School Age (Hirschsprung)
Primary Purpose
Hirschsprung's Disease (HD)
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
psychometric evaluation
neuropsychological evaluation
Sponsored by
About this trial
This is an interventional supportive care trial for Hirschsprung's Disease (HD)
Eligibility Criteria
Inclusion Criteria:
- Child aged 8 to 13
- Child with Hirschsprung's disease (diagnosis confirmed by anatomopathological analysis),
- Child with no severe cerebral palsy
- Child with no developmental psychosis
- Child not showing amblyopia
- Child not deaf hearing
- Child able to answer a questionnaire in French language,
- a child whose parents or legal representatives have accepted the principle of participation in this study, and who have signed an informed consent,
Exclusion Criteria:
- Child deceased between birth and the date of assessment,
- Child with cerebral palsy
- Child whose parents or legal representatives refused to allow their child to participate in this study
Sites / Locations
- Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Child with Hirschsprung's disease
Arm Description
Neuropsychological assessment at elementary school
Outcomes
Primary Outcome Measures
Evaluation of a sensory deficit
Administration d'un test psychometric de type Wechsler. The Wechsler Intelligence Scale for Children (WISC). The WISC-IV includes 15 subtests exploring four major components assessing the different intellectual skills essential to learning processes. The minimum score is 70, the normality between 90 ant 110, the maximum score is 130.
Secondary Outcome Measures
Evaluation of child behavior by the Goodman questionnaire: Strengths and Difficulties Questionnaire (SDQ).
It includes 25 questions that are asked to parents. It is used within research, evaluating treatment outcome and as part of clinical assessment in order to examine a child's mental well-being. A total difficulties score is calculated using the SDQ, which ranges from 0-40. Each 1 point increase in the total difficulties score corresponds with an increase in the risk of developing a mental health disorder. Categories have been proposed by Youth in Mind authors in order to assess whether a child's score is close to average, slightly above average, high or very high.
Full Information
NCT ID
NCT03406741
First Posted
January 16, 2018
Last Updated
May 26, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03406741
Brief Title
Neuropsychological Development and Functional Outcome Sin Children With Hirschsprung Disease at School Age
Acronym
Hirschsprung
Official Title
Neuropsychological Development and Functional Outcome Sin Children With Hirschsprung Disease at School Age - Hirschsprung
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
May 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hirschsprung's disease (HD) is a rare congenital disease (1:5000) characterized by neonatal functional low bowel obstruction that is caused by aganglionosis of the distal bowel. HD treatment consists in surgery of colonic reduction in the early childhood, requiring afterward a long-term follow-up. In the long term complications (incontinence, constipation, enterocolitis, soiling)but also iterative anesthesia in childhood and repeated hospitalizations can have negative effects on child's development.
The main aim of the study is to estimate neuropsychological development at school age (6-10 years). Of children operated of HD Secondary aims are evaluation of the neuro-driving development and global health, comparison of quality of life levels to those of French population standards as well as to study the complex relations between on one hand the quality of life of these children and on the other hand the socio-demographic data, the initial clinical elements and the surgical coverage, as well as their health and current cognitive profile.
This multicenter study included pediatric surgery departments of Marseille. All children born between 1/1/2005 and 31/12/2010 and presenting HD represent the population. All the families will be contacted resting on the networks of set up follow-up. A written agreement will be collected with the parents. For all the participating children, a consultation will be organized: quality of life data (reported by children and by their parents in validated standardized questionnaires), clinical examination of the child, cognitive profile of the child. The duration of inclusion is scheduled for 12 months.
This is the first French study using auto-reported data on children's quality of life at school age affected by a HD. The results of this study will allow developing hypotheses on predictive risk factors for neuropsychological development disorders. Besides a better knowledge of the relation existing between these children quality of life and their functional results due to the disease could help clinicians in their medical reflections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hirschsprung's Disease (HD)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Child with Hirschsprung's disease
Arm Type
Experimental
Arm Description
Neuropsychological assessment at elementary school
Intervention Type
Behavioral
Intervention Name(s)
psychometric evaluation
Intervention Description
Wechsler type composite scales (WISC)
Intervention Type
Behavioral
Intervention Name(s)
neuropsychological evaluation
Intervention Description
Evaluation of child behavior by the Goodman questionnaire: Strengths and Difficulties Questionnaire
Primary Outcome Measure Information:
Title
Evaluation of a sensory deficit
Description
Administration d'un test psychometric de type Wechsler. The Wechsler Intelligence Scale for Children (WISC). The WISC-IV includes 15 subtests exploring four major components assessing the different intellectual skills essential to learning processes. The minimum score is 70, the normality between 90 ant 110, the maximum score is 130.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluation of child behavior by the Goodman questionnaire: Strengths and Difficulties Questionnaire (SDQ).
Description
It includes 25 questions that are asked to parents. It is used within research, evaluating treatment outcome and as part of clinical assessment in order to examine a child's mental well-being. A total difficulties score is calculated using the SDQ, which ranges from 0-40. Each 1 point increase in the total difficulties score corresponds with an increase in the risk of developing a mental health disorder. Categories have been proposed by Youth in Mind authors in order to assess whether a child's score is close to average, slightly above average, high or very high.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Child aged 8 to 13
Child with Hirschsprung's disease (diagnosis confirmed by anatomopathological analysis),
Child with no severe cerebral palsy
Child with no developmental psychosis
Child not showing amblyopia
Child not deaf hearing
Child able to answer a questionnaire in French language,
a child whose parents or legal representatives have accepted the principle of participation in this study, and who have signed an informed consent,
Exclusion Criteria:
Child deceased between birth and the date of assessment,
Child with cerebral palsy
Child whose parents or legal representatives refused to allow their child to participate in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD, Director
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Neuropsychological Development and Functional Outcome Sin Children With Hirschsprung Disease at School Age
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