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

NCT03210675 | Unknown

• 1 other identifier: DP-TRS-T21
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Obstructive Sleep Apnea of Newborn

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Study group

OTHER

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)

Standard Care Group

OTHER

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)

Interventions

Polysomnography (PSG) DIAGNOSTIC_TEST

PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years

Standard Care Group; Study group

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Jerome Lejeune: lead
• Hôpital Necker-Enfants Malades: collaborator

Study Sites (1)

Institut Jérome Lejeune

Paris, 75015, France

Location

Related Publications (8)

• 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.

  PMID: 25644910 BACKGROUND

• 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.

  PMID: 12833493 BACKGROUND

• 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.

  PMID: 16596369 BACKGROUND

• 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.

  PMID: 20452066 BACKGROUND

• 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.

  PMID: 22926176 BACKGROUND

• 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.

  PMID: 24471822 BACKGROUND

• 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.

  PMID: 21788214 BACKGROUND

• 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.

  PMID: 18296460 BACKGROUND

Related Links

• Sponsor and site investigator
• Site investigator for PSG evaluation

MeSH Terms

Conditions

Down Syndrome

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Brigitte FAUROUX, Professor

  Hôpital Necker-Enfants Malade

  STUDY CHAIR

• Clotilde MIRCHER, Doctor

  Institut Jérôme Lejeune

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, comparative, open label, multi-center study

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 7, 2017
• Study Start: July 31, 2017
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

FR (1)