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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease Intervention/treatment Phase
Hirschsprung's Disease (HD) Behavioral: psychometric evaluation Behavioral: neuropsychological evaluation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Catherine GIRE, PH 491968750 ext +33 catherine.gire@ap-hm.fr
Contact: Jean DHORNE, Manager 491381475 ext +33 jean.dhorne@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Catherine GIRE, PH    491968750 ext +33    catherine.gire@ap-hm.fr   
Principal Investigator: Catherine GIRE, PH         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD, Director Assistance Publique Hôpitaux de Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03406741    
Other Study ID Numbers: 2017-13
2017-A01224-49 ( Registry Identifier: ID RCB )
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hirschsprung Disease
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities