Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/105013
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Type: Journal article
Title: Rationale for and design of the "POSTA" study: evaluation of neurocognitive outcomes after immediate adenotonsillectomy compared to watchful waiting in preschool children
Author: Waters, K.
Chawla, J.
Harris, M.
Dakin, C.
Heussler, H.
Black, R.
Cheng, A.
Burns, H.
Kennedy, J.
Lushington, K.
Citation: BMC Pediatrics, 2017; 17(1):47-1-47-7
Publisher: BioMed Central
Issue Date: 2017
ISSN: 1471-2431
1471-2431
Statement of
Responsibility: 
Karen A. Waters, Jasneek Chawla, Margaret-Anne Harris, Carolyn Dakin, Helen Heussler, Robert Black, Alan Cheng, Hannah Burns, John D. Kennedy and Kurt Lushington
Abstract: Background: IQ deficits are linked to even mild obstructive sleep apnoea (OSA) in children. Although OSA is commonly first diagnosed in the pre-school age group, a randomised trial is still needed to assess IQ outcomes after adenotonsillectomy in the pre-school age-group. This randomised control trial (RCT) will primarily determine whether adenotonsillectomy improves IQ compared to no adenotonsillectomy after 12 months, in preschool (3–5 year-old) children with mild to moderate OSA. Methods: This protocol is for an ongoing multi-centred RCT with a recruitment target of 210 subjects (105 in each arm). Children age 3–5 years with symptoms of OSA, are recruited through doctor referral, at the point of referral to the Ear Nose and Throat (ENT) services. Screening is initially with a questionnaire (Paediatric Sleep Questionnaire, PSQ) for symptoms of obstructive sleep apnoea (OSA). Where questionnaires are positive (suggestive of OSA) and ENT surgeons recommend them for adenotonsillectomy, they are invited to participate in POSTA. Baseline testing includes neurocognitive testing (IQ and psychometric evaluation with the neuropsychologist blinded to randomisation) and overnight polysomnography (PSG). Where the Obstructive Apnoea-Hypopnea Index (OAHI) from the PSG is <10/h per hour, consent for randomisation is sought; children with severe OSA (OAHI ≥ 10/h) are sent for immediate treatment and excluded from the study. After consent is obtained, participants are randomised to early surgery (within 2 months) or to surgery after a usual wait time of 12 months. Follow-up studies include repeat neurocognitive testing and PSG at 12 (with the waiting list group studied before their surgery) and 24 months after randomisation. Analysis will be by intention to treat. The primary outcome is IQ at 12 months’ follow-up. Discussion: If IQ deficits associated with OSA are reversible 12 months after adenotonsillectomy compared to controls, future clinical practice advise would be to undertake early surgery in young children with OSA. The study could provide data on whether a window of opportunity exists for reversing IQ deficits linked to OSA in the pre-school age-group. Trial registration: Australian and New Zealand Clinical Trials Registration Number ACTRN12611000021976.
Keywords: Intelligence; neurocognition; pre-school; child; sleep disordered breathing; tonsillectomy; adenotonsillectomy; clinical trial
Rights: © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
DOI: 10.1186/s12887-016-0758-8
Grant ID: http://purl.org/au-research/grants/nhmrc/1049788
Appears in Collections:Aurora harvest 8
Paediatrics publications

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