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NCT03210675 Clinical Trial

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

Down Syndrome Clinical Trial

— RESPIRE21  

Official title:
Early Detection and Treatment of Respiratory Sleep Disorders in Children With Down Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03210675
Other study ID # DP-TRS-T21
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 31, 2017
Est. completion date June 30, 2024

Study information
Verified date February 2023
Source Institut Jerome Lejeune
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 80
Est. completion date June 30, 2024
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Months to 3 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Polysomnography (PSG)
PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years

Locations
Country Name City State
France Institut Jérome Lejeune Paris

Sponsors (2)
Lead Sponsor Collaborator
Institut Jerome Lejeune Hôpital Necker-Enfants Malades

Country where clinical trial is conducted

France, 

References & Publications (8)

Bertrand P, Navarro H, Caussade S, Holmgren N, Sanchez I. Airway anomalies in children with Down syndrome: endoscopic findings. Pediatr Pulmonol. 2003 Aug;36(2):137-41. doi: 10.1002/ppul.10332. — View Citation

Breslin J, Spano G, Bootzin R, Anand P, Nadel L, Edgin J. Obstructive sleep apnea syndrome and cognition in Down syndrome. Dev Med Child Neurol. 2014 Jul;56(7):657-64. doi: 10.1111/dmcn.12376. Epub 2014 Jan 29. — View Citation

Bull MJ; Committee on Genetics. Health supervision for children with Down syndrome. Pediatrics. 2011 Aug;128(2):393-406. doi: 10.1542/peds.2011-1605. Epub 2011 Jul 25. Erratum In: Pediatrics. 2011 Dec;128(6):1212. — View Citation

Ellis JM, Tan HK, Gilbert RE, Muller DP, Henley W, Moy R, Pumphrey R, Ani C, Davies S, Edwards V, Green H, Salt A, Logan S. Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial. BMJ. 2008 Mar 15;336(7644):594-7. doi: 10.1136/bmj.39465.544028.AE. Epub 2008 Feb 21. — View Citation

Fricke BL, Donnelly LF, Shott SR, Kalra M, Poe SA, Chini BA, Amin RS. Comparison of lingual tonsil size as depicted on MR imaging between children with obstructive sleep apnea despite previous tonsillectomy and adenoidectomy and normal controls. Pediatr Radiol. 2006 Jun;36(6):518-23. doi: 10.1007/s00247-006-0149-7. Epub 2006 Apr 5. — View Citation

Lal C, White DR, Joseph JE, van Bakergem K, LaRosa A. Sleep-disordered breathing in Down syndrome. Chest. 2015 Feb;147(2):570-579. doi: 10.1378/chest.14-0266. — View Citation

Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27. — View Citation

Shires CB, Anold SL, Schoumacher RA, Dehoff GW, Donepudi SK, Stocks RM. Body mass index as an indicator of obstructive sleep apnea in pediatric Down syndrome. Int J Pediatr Otorhinolaryngol. 2010 Jul;74(7):768-72. doi: 10.1016/j.ijporl.2010.03.050. Epub 2010 May 7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Griffith Mental Development Scale (GMDS) scores Mean Griffith Mental Development Scale (GMDS) scores at the age of 3 years will be compared between the 2 groups At the age of 3 years
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