Down Syndrome, Obstructive Sleep Apnea of Newborn
Conditions
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.
Interventions
DIAGNOSTIC_TESTPolysomnography (PSG)
PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years
Sponsors
Hôpital Necker-Enfants Malades
Institut Jerome Lejeune
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Interventional, comparative, open label, multi-center study
Eligibility
Sex/Gender
ALL
Age
6 Months to 3 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Griffith Mental Development Scale (GMDS) scores | 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 |
Countries
France
Outcome results
None listed