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

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: NCT03210675
Recruitment Status : Active, not recruiting
First Posted : July 7, 2017
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Hôpital Necker-Enfants Malades
Information provided by (Responsible Party):
Institut Jerome Lejeune

Tracking Information
First Submitted Date  ICMJE July 5, 2017
First Posted Date  ICMJE July 7, 2017
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE July 31, 2017
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Detection and Treatment of Respiratory Sleep Disorders in Children With Down Syndrome
Official Title  ICMJE Early Detection and Treatment of Respiratory Sleep Disorders in Children With Down Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Interventional, comparative, open label, multi-center study
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Down Syndrome
  • Obstructive Sleep Apnea of Newborn
Intervention  ICMJE Diagnostic Test: Polysomnography (PSG)
PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: Polysomnography (PSG)
  • 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
    Intervention: Diagnostic Test: Polysomnography (PSG)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03210675
Other Study ID Numbers  ICMJE DP-TRS-T21
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Jerome Lejeune
Study Sponsor  ICMJE Institut Jerome Lejeune
Collaborators  ICMJE Hôpital Necker-Enfants Malades
Investigators  ICMJE
Study Chair: Brigitte FAUROUX, Professor Hôpital Necker-Enfants Malade
Principal Investigator: Clotilde MIRCHER, Doctor Institut Jérôme Lejeune
PRS Account Institut Jerome Lejeune
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP