Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000021976
Ethics application status
Approved
Date submitted
13/12/2010
Date registered
7/01/2011
Date last updated
11/06/2019
Date data sharing statement initially provided
11/06/2019
Date results information initially provided
11/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The POSTA Child Study (Preschool Obstructive Sleep Apnoea (OSA) Tonsillectomy, Adenoidectomy Child Study)
Scientific title
The POSTA Child Study (Preschool Obstructive Sleep Apnoea (OSA) Tonsillectomy, Adenoidectomy Child Study).
Preschool children with mild to moderate OSA improve their IQ if they undergo immediate adenotonsillectomy compared to matched counterparts who have delayed adenotonsillectomy.
Secondary ID [1] 253158 0
Nil
Universal Trial Number (UTN)
U1111-1117-2128
Trial acronym
POSTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 258706 0
Condition category
Condition code
Respiratory 258861 258861 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective randomised controlled trial in adenotonsillectomy in preschool aged children with mild to moderate OSA. Children will be randomised into either the "Early Intervention" group (early surgery - adenotonsillectomy within two months of randomisation) or "Delayed Intervention" group (usual 12 month surgical wait list for adenotonsillectomy). Children will also undergo the following tests at baseline, 12 months and 24 months: polysomnography, lateral airways x-ray, IQ and behavioural testing.
Intervention is Adenotonsillectomy surgery, which is a standardised surgical technique. All children will undergo complete extra-capsular tonsillectomy and adenoidectomy, regardless of the size of the adenoids. The adenoidal bed will be visualized at the end of the procedure, to ensure the adenoidectomy is satisfactorily complete. It has been agreed that diathermy for adenoids is acceptable.

This is a 5 year study. Recruitment will last over a period of 5 years, in case of patient drop out from the study. However, each participant is seen upto 24 months after surgery.
Intervention code [1] 257662 0
Treatment: Surgery
Intervention code [2] 257663 0
Behaviour
Comparator / control treatment
There is a Delayed Intervention group (on the usual 12 month waitlist for surgery).
Control group
Active

Outcomes
Primary outcome [1] 259714 0
IQ is improved by early surgery assessed by neurocognitive and beahvioural testing.
Timepoint [1] 259714 0
at baseline, at 12 months and 24 months.
Primary outcome [2] 259715 0
Linear regression (analysis of co-variance)
Timepoint [2] 259715 0
at baseline, at 12 months and 24 months.
Secondary outcome [1] 266436 0
Higher IQ in children who undergo immediate surgery assessed by neurocognitive and behavioural testing.
Timepoint [1] 266436 0
at baseline, at 12 months and 24 months.
Secondary outcome [2] 266437 0
Linear regression (analysis of co-variance)
Timepoint [2] 266437 0
at baseline, at 12 months and 24 months.

Eligibility
Key inclusion criteria
Children with enlarged adenoids and tonsils and are suitable for adenotonsillectomy.
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with medical conditions known to affect neurocognitive development (including hearing loss of >35 DB) in both ear, previous tonsillectomy or airway surgery, genetic and craniofacial syndromes that are known to have high risk for severe OSA, identified neurodevelopmental conditions, cyanotic heart disease or previous cardiopulmonary bypass, and conditions that preclude neurocognitive testing such as not able to understand and speak age appropriate English will be excluded from enrolment in the study. Children found to have severe OSA OAHI >10/h) on sleep study will be excluded because it is considered unethical to delay treatment in this group, who have risk for morbidities other than neurocognitive deficit

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be centralised at the main coordinating center , Childrens Hospital at Westmead .Statistician will generate the randomisation list to ensure that the process is concealed from the study research staff. The secretary who is not connected to the study will access the system at the point of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
17/07/2010
Actual
17/07/2010
Date of last participant enrolment
Anticipated
Actual
31/08/2017
Date of last data collection
Anticipated
31/10/2019
Actual
Sample size
Target
188
Accrual to date
Final
193
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment postcode(s) [1] 8062 0
2037 - Glebe
Recruitment postcode(s) [2] 3477 0
2145
Recruitment postcode(s) [3] 3478 0
4101
Recruitment postcode(s) [4] 3479 0
5005
Recruitment postcode(s) [5] 3480 0
5006

Funding & Sponsors
Funding source category [1] 258133 0
University
Name [1] 258133 0
The University of Sydney
Country [1] 258133 0
Australia
Funding source category [2] 258134 0
Charities/Societies/Foundations
Name [2] 258134 0
Resmed Foundation
Country [2] 258134 0
United States of America
Funding source category [3] 289198 0
Government body
Name [3] 289198 0
NHMRC
Country [3] 289198 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Cnr. Hawkesbury Road & Hainsworth Street
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 257372 0
Charities/Societies/Foundations
Name [1] 257372 0
Resmed Foundation
Address [1] 257372 0
PO Box 2448
La Jolla, CA 92038
Country [1] 257372 0
United States of America
Other collaborator category [1] 251675 0
Individual
Name [1] 251675 0
Dr Alan Cheng
Address [1] 251675 0
ENT Department,
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country [1] 251675 0
Australia
Other collaborator category [2] 251676 0
Individual
Name [2] 251676 0
Sara Coombes
Address [2] 251676 0
Kids Rehab,
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country [2] 251676 0
Australia
Other collaborator category [3] 251677 0
Individual
Name [3] 251677 0
Dr Margaret Harris
Address [3] 251677 0
Respiratory Medicine,
Lady Cilento Childrens Hospital
501 Stanley Street
South Brisbane QLD 4101
Country [3] 251677 0
Australia
Other collaborator category [4] 251678 0
Individual
Name [4] 251678 0
A/Prof Robert Black
Address [4] 251678 0
Lady Cilento Childrens Hospital
501 Stanley Street
South Brisbane QLD 4101
Country [4] 251678 0
Australia
Other collaborator category [5] 251679 0
Individual
Name [5] 251679 0
A/Prof Declan Kennedy
Address [5] 251679 0
The University of Adelaide,
North Terrace, Adelaide SA 5005
Country [5] 251679 0
Australia
Other collaborator category [6] 251680 0
Individual
Name [6] 251680 0
Dr Mark Schembri
Address [6] 251680 0
ENT Department, Women's and Children's Hospital
55 King William Road, North Adelaide, SA 5006
Country [6] 251680 0
Australia
Other collaborator category [7] 277931 0
Individual
Name [7] 277931 0
A/Prof Helen Heussler
Address [7] 277931 0
Respiratory and Sleep Medicine
Lady Cilento Childrens Hospital
501 Stanley Street
South Brisbane QLD 4101
Country [7] 277931 0
Australia
Other collaborator category [8] 277932 0
Individual
Name [8] 277932 0
Professor Kurt Lushington
Address [8] 277932 0
School of Psychology, Social Work and Social policy
University of South Australia
GPO Box 2471
Adelaide
SA 5000
Country [8] 277932 0
Australia
Other collaborator category [9] 277933 0
Individual
Name [9] 277933 0
Jasneek Chawla
Address [9] 277933 0
Respiratory and Sleep Medicine
Lady Cilento Childrens Hospital
501 Stanley Street
South Brisbane QLD 4101
Country [9] 277933 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260113 0
Royal Alexandra Hospital for Children Ethics Committee (EC00130)
Ethics committee address [1] 260113 0
The Children's Hospital at Westmead
Corner Hawkesbury Road and Hainsworth Street,
Locked Bag 4001, Westmead NSW 2145
Ethics committee country [1] 260113 0
Australia
Date submitted for ethics approval [1] 260113 0
22/05/2008
Approval date [1] 260113 0
19/12/2008
Ethics approval number [1] 260113 0
08/CHW/54
Ethics committee name [2] 300883 0
Sydney Children’s Hospitals Network Human Research Ethics Committee
Ethics committee address [2] 300883 0
Corner Hawkesbury Road
and Hainsworth Street
Locked Bag 4001
Westmead NSW 2145
Sydney Australia
DX 8213 Parramatta
Ethics committee country [2] 300883 0
Australia
Date submitted for ethics approval [2] 300883 0
29/07/2014
Approval date [2] 300883 0
05/09/2014
Ethics approval number [2] 300883 0
HREC/ 14/SCHN/332

Summary
Brief summary
This is a 5-year multicenter trial. Children with a history suggestive of OSA and deemed suitable for adenotonsillectomy (T&A) by an otolaryngologist are eligible to participate in an overnight sleep study (PSG). If the PSG demonstrates mild to moderate OSA OAHI< 10/hr), they will be recruited randomised to receive early (treatment group), or routine (control group) adenotonsillectomy (treatment intervention).The outcome sought is a clinically meaningful improvement in the neurocognitive testing scores, which has been
defined as an improvement of 4 IQ points.
The primary outcome of the study are intelligence quotient (IQ) and behavioural scores. The IQ and behaviour will be assessed after the PSG result but before randomisation. The PSG, IQ and behaviour tests will be repeated at follow-up 12 months later. After follow-up at 12 months, the control group will proceed to T&A and at 24 months, the treatment and the control groups will have PSG, IQ and behaviour tests repeated for the third time.
Rationale: Previous studies have demonstrated that children with OSA have lower IQ scores and more disturbed behaviour than age-matched counterparts who do not snore. No randomized trials have been undertaken to evaluate whether the abnormalities improve after treatment.
The participants in this study will have overnight sleep studies and neuropsychological testing at three time points. The first is at baseline before T&A. One group will have T&A after randomisation and the first follow-up (12 months after randomisation) will assess changes for treatment (T&A) vs non-treatment (waiting). after 12 months follow-up, the second group will also undergo T&A. The second assessment (24 months after randomisation) whether a 12 month delay to T&A affects outcomes.
The first assessment will allow us to determine whether adenotonsillectomy (T&A) improves IQ and behavioural deficits in 3-5 yr-old children compared to no T&A. We hypothesize that T&A produces improvements in IQ and in
behaviour. The second assessment will allow us to determine whether there is any difference in the level of improvement achieved after early compared to late (12 month delayed) T&A.
Trial website
Trial related presentations / publications
Rationale for and design of the "POSTA"
study: Evaluation of neurocognitive outcomes
after immediate adenotonsillectomy
compared to watchful waiting in preschool
children
Karen A. Waters* , Jasneek Chawla, Margaret-Anne Harris, Carolyn Dakin, Helen Heussler, Robert Black
Alan Cheng, Hannah Burns John D. Kennedy and Kurt Lushington

Waters et al. BMC Pediatrics (2017) 17:47
DOI 10.1186/s12887-016-0758-8
Public notes

Contacts
Principal investigator
Name 31951 0
Prof Karen Waters
Address 31951 0
Department of Respiratory Medicine
The Childrens Hospital at Westmead
Locked Bag 4001
Westmead, NSW 2145
Country 31951 0
Australia
Phone 31951 0
+612-9845-53444
Fax 31951 0
Email 31951 0
karen.waters@health.nsw.gov.au
Contact person for public queries
Name 15198 0
Dr Sarbjeet kaur
Address 15198 0
Sleep Research
Clinical Sciences
Locked Bag 4001
Westmead NSW 2145
Country 15198 0
Australia
Phone 15198 0
61 2 9845 1318
Fax 15198 0
612 9845 1317
Email 15198 0
sarbjeet.kaur@health.nsw.gov.au
Contact person for scientific queries
Name 6126 0
Prof Karen Waters
Address 6126 0
Department of Respiratory Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 6126 0
Australia
Phone 6126 0
+61 2 9845 3444
Fax 6126 0
61 2 9845 3396
Email 6126 0
karen.waters@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual details are confidential and will exist with the principal investigator. However protocol and study reports are available for sharing


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23183Study protocol    336273-(Uploaded-17-06-2021-14-11-44)-Study-related document.docx
23184Clinical study report    336273-(Uploaded-17-06-2021-14-13-01)-Study-related document.docx
23826Other    Published paper details provided

Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Other filesNo Sleep Down under 2018
Study results articleYes Rationale for and design of the "POSTA" study: Eva... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRationale for and design of the "POSTA" study: Evaluation of neurocognitive outcomes after immediate adenotonsillectomy compared to watchful waiting in preschool children.2017https://dx.doi.org/10.1186/s12887-016-0758-8
EmbaseCognition after early tonsillectomy for mild OSA.2020https://dx.doi.org/10.1542/peds.2019-1450
EmbaseCognitive parameters in children with mild obstructive sleep disordered breathing.2021https://dx.doi.org/10.1007/s11325-020-02264-1
N.B. These documents automatically identified may not have been verified by the study sponsor.