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Completed
NCT03210675
Early Detection and Treatment of Obstructive Sleep Apnoea in Infants With Down Syndrome
Conditions: Down Syndrome, Obstructive Sleep Apnea of Newborn
Sex: All
Ages: 6 Months – 3 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Institut Jerome Lejeune
Location: Institut Jérome Lejeune Paris Sélectionnez l'État/Province
Summary
Interventional, comparative, open-label, single-center study to demonstrate that early (from 6 months of age) and systematic (every 6 months) screening for Obstructive Sleep Apnoea (OSA) by polysomnography (PSG) in infants with Down syndrome during the first 3 years of life is associated with improved neurodevelopment at 3 years of age, with sustained benefits up to 5 years of age.
Eligibility 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
Source: ClinicalTrials.gov (NCT03210675). StuddyBuddy aggregates publicly available trial information.