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

Primary Purpose

Down Syndrome, Obstructive Sleep Apnea of Newborn

Status

Active

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Polysomnography (PSG)

About this trial

This is an interventional prevention trial for Down Syndrome

Eligibility Criteria

6 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut Jérome Lejeune

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Study group

Standard Care Group

Arm Description

Will have a PSG at home every 6 months (± 1 month) from the age of 6 months until the age of 3 years.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03210675

First Posted

July 5, 2017

Last Updated

February 7, 2023

Sponsor

Institut Jerome Lejeune

Collaborators

Hôpital Necker-Enfants Malades

1. Study Identification

Unique Protocol Identification Number

NCT03210675

Brief Title

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

Acronym

RESPIRE21

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 31, 2017 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Jerome Lejeune

Collaborators

Hôpital Necker-Enfants Malades

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Down Syndrome, Obstructive Sleep Apnea of Newborn

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Interventional, comparative, open label, multi-center study

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Other

Arm Description

Will have a PSG at home every 6 months (± 1 month) from the age of 6 months until the age of 3 years.

Arm Title

Standard Care Group

Arm Type

Other

Arm Description

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 Type

Diagnostic Test

Intervention Name(s)

Polysomnography (PSG)

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Griffith Mental Development Scale (GMDS) scores

Description

Mean Griffith Mental Development Scale (GMDS) scores at the age of 3 years will be compared between the 2 groups

Time Frame

At the age of 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brigitte FAUROUX, Professor

Organizational Affiliation

Hôpital Necker-Enfants Malade

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Clotilde MIRCHER, Doctor

Organizational Affiliation

Institut Jérôme Lejeune

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Jérome Lejeune

City

Paris

ZIP/Postal Code

75015

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

25644910

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.

Results Reference

background

PubMed Identifier

12833493

Citation

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.

Results Reference

background

PubMed Identifier

16596369

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.

Results Reference

background

PubMed Identifier

20452066

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.

Results Reference

background

PubMed Identifier

22926176

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.

Results Reference

background

PubMed Identifier

24471822

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.

Results Reference

background

PubMed Identifier

21788214

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.

Results Reference

background

PubMed Identifier

18296460

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.

Results Reference

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Links:

URL

http://www.institutlejeune.org/

Description

Sponsor and site investigator

URL

http://vnietsommeil.aphp.fr/

Description

Site investigator for PSG evaluation

Learn more about this trial

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

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