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Trial record 65 of 165 for:    trisomy21 NOT prenatal

Early Detection and Treatment of Respiratory Sleep Disorders in Children With Down Syndrome (RESPIRE21)

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ClinicalTrials.gov Identifier: NCT03210675
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
Hôpital Necker-Enfants Malades
Information provided by (Responsible Party):
Institut Jerome Lejeune

Brief Summary:
Interventional, comparative, open label, single-center study to demonstrate that an early (from 6 months of age) and systematic (every 6 months) screening of Obstructive Sleep Apnea (OSA) by polysomnography (PSG) in children with Down Syndrome during the first 3 years of life is associated with an improved neurocognitive development at the age of 3 years.

Condition or disease Intervention/treatment Phase
Down Syndrome Obstructive Sleep Apnea of Newborn Diagnostic Test: Polysomnography (PSG) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Interventional, comparative, open label, multi-center study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Detection and Treatment of Respiratory Sleep Disorders in Children With Down Syndrome
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Study group
Will have a PSG at home every 6 months (± 1 month) from the age of 6 months until the age of 3 years.
Diagnostic Test: Polysomnography (PSG)
PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years

Standard Care Group
Will have a single PSG at home which will give a reference in the Down Syndrome population of 3 years old and will be used as reference to the study group
Diagnostic Test: Polysomnography (PSG)
PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years




Primary Outcome Measures :
  1. Mean Griffith Mental Development Scale (GMDS) scores [ Time Frame: At the age of 3 years ]
    Mean Griffith Mental Development Scale (GMDS) scores at the age of 3 years will be compared between the 2 groups



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Ages Eligible for Study:   6 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

Down Syndrome Age 6 months or less for the Study Group Age 30 to 36 months for the Standard Care Group Living in Paris or Paris area (75, 77, 78, 92, 93, 94, 95) Parents or legal representative agreeing with the study requirements and able to understand, date and sign the informed consent form before study enrollment French language is native mother tongue

Exclusion criteria :

Gestationnel age < 36 completed amenorrhoea weeks Patient who have or had acute CNS suffering signs Patients with Down Syndrome already had continuous positive airway pressure treatment for OSA Patients participating in another clinical study or for whom a participation to another biomedical research is expected before the end or their follow-up


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): NCT03210675


Contacts
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Contact: Isabelle MAREY, PI +33 1 56 58 63 00 isabelle.marey@institutlejeune.org
Contact: Hervé WALTI +33 1 56 58 63 00 herve.walti@institutlejeune.org

Locations
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France
Institut Jérome Lejeune Recruiting
Paris, France, 75015
Contact: Claire Rakic    01 56 58 63 00    contatct@institutlejeune.org   
Principal Investigator: Isabelle Marey, MD         
Sub-Investigator: Hervé Walti, Professor         
Sub-Investigator: Aimé Ravel, MD         
Sub-Investigator: Clotilde Mircher, MD         
Sub-Investigator: Cécile Cieuta-Walti, MD         
Sub-Investigator: Jeanne Toulas, MD         
Sponsors and Collaborators
Institut Jerome Lejeune
Hôpital Necker-Enfants Malades
Investigators
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Study Chair: Brigitte FAUROUX, Professor Hôpital Necker-Enfants Malade

Additional Information:
Publications:

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Responsible Party: Institut Jerome Lejeune
ClinicalTrials.gov Identifier: NCT03210675     History of Changes
Other Study ID Numbers: DP-TRS-T21
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

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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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Down Syndrome
Syndrome
Sleep Apnea, Obstructive
Sleep Wake Disorders
Parasomnias
Disease
Pathologic Processes
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Intellectual Disability
Neurobehavioral Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn