Rationale for and design of the "POSTA" study: Evaluation of neurocognitive outcomes after immediate adenotonsillectomy compared to watchful waiting in preschool children

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 .Pediatrics. 1998 Sep;102(3 Pt 1):616-20. (PMID: 9738185); N Engl J Med. 2013 Jun 20;368(25):2366-76. (PMID: 23692173); J Sleep Res. 2004 Jun;13(2):165-72. (PMID: 15175097); J Pediatr. 2004 Oct;145(4):458-64. (PMID: 15480367); Child Adolesc Psychiatr Clin N Am. 2009 Oct;18(4):813-23. (PMID: 19836689); Pediatrics. 2004 Oct;114(4):1041-8. (PMID: 15466103); Am J Respir Crit Care Med. 2003 Aug 15;168(4):464-8. (PMID: 12773324); Anaesth Intensive Care. 2004 Feb;32(1):43-6. (PMID: 15058120); Am J Respir Crit Care Med. 2001 Jul 1;164(1):16-30. (PMID: 11435234); Sleep Med. 2000 Feb 1;1(1):21-32. (PMID: 10733617); Pediatrics. 2004 Jul;114(1):44-9. (PMID: 15231906); Pediatr Pulmonol. 2004 Apr;37(4):330-7. (PMID: 15022130); Lancet. 2004 Aug 28-Sep 3;364(9436):803-11. (PMID: 15337409); Pediatrics. 2006 Oct;118(4):e1100-8. (PMID: 17015501); Child Neuropsychol. 2002 Jun;8(2):71-82. (PMID: 12638061); Pediatrics. 2008 Jul;122(1):75-82. (PMID: 18595989); Sleep. 1997 Dec;20(12):1185-92. (PMID: 9493930); J Laryngol Otol. 2013 Jan;127 Suppl 1:S26-9. (PMID: 22947267); Arch Phys Med Rehabil. 2008 Dec;89(12 Suppl):S16-24. (PMID: 19081437); Thorax. 2005 Jun;60(6):511-6. (PMID: 15923253); Sleep. 2010 Nov;33(11):1447-56. (PMID: 21102986); Sleep. 2006 Sep;29(9):1115-34. (PMID: 17040000); N Engl J Med. 2013 Jun 20;368(25):2428-9. (PMID: 23692171); Pediatrics. 2012 Sep;130(3):576-84. (PMID: 22926173); Dev Sci. 2006 Jul;9(4):411-27. (PMID: 16764614); Int J Pediatr Otorhinolaryngol. 2011 Nov;75(11):1385-90. (PMID: 21871668); Pediatrics. 2001 Jun;107(6):1394-9. (PMID: 11389263); J Clin Exp Neuropsychol. 2000 Oct;22(5):554-68. (PMID: 11094391); Sleep. 2013 Jul 1;36(7):1077-1084. (PMID: 23814345). Linking ISSN: 14712431. Subset: MEDLINE; Date of Electronic Publication: 2017 Feb 02. ; Original Imprints: Publication: London : BioMed Central, [2001- <br />