Neuropsychological Development and Functional Outcome Sin Children With Hirschsprung Disease at School Age (Hirschsprung)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03406741|
Recruitment Status : Unknown
Verified January 2018 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Recruiting
First Posted : January 23, 2018
Last Update Posted : January 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Hirschsprung's Disease (HD)||Behavioral: psychometric evaluation Behavioral: neuropsychological evaluation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Neuropsychological Development and Functional Outcome Sin Children With Hirschsprung Disease at School Age - Hirschsprung|
|Actual Study Start Date :||January 17, 2018|
|Estimated Primary Completion Date :||January 17, 2019|
|Estimated Study Completion Date :||January 17, 2020|
Experimental: Child with Hirschsprung's disease
Neuropsychological assessment at elementary school
Behavioral: psychometric evaluation
Wechsler type composite scales (WISC)
Behavioral: neuropsychological evaluation
Evaluation of child behavior by the Goodman questionnaire: Strengths and Difficulties Questionnaire
- Evaluation of a sensory deficit [ Time Frame: 12 months ]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.
- Evaluation of child behavior by the Goodman questionnaire: Strengths and Difficulties Questionnaire (SDQ). [ Time Frame: 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406741
|Contact: Catherine GIRE, PH||491968750 ext +email@example.com|
|Contact: Jean DHORNE, Manager||491381475 ext +firstname.lastname@example.org|
|Assistance Publique Hôpitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: Catherine GIRE, PH 491968750 ext +33 email@example.com|
|Principal Investigator: Catherine GIRE, PH|
|Study Director:||Jean-Olivier ARNAUD, Director||Assistance Publique Hôpitaux de Marseille|