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

BMC Pediatrics

Study Protocol

Alan Cheng¹  Karen A. Waters²  Robert Black³  Margaret-Anne Harris³  Helen Heussler³  Hannah Burns³  Jasneek Chawla³  Carolyn Dakin⁴  Kurt Lushington⁵  John D. Kennedy⁶ 

[1] The Children’s Hospital at Westmead, 2145, Sydney, NSW, Australia;The Children’s Hospital at Westmead, 2145, Sydney, NSW, Australia;The University of Sydney, Sydney, Australia;The Lady Cilento Children’s Hospital, Brisbane, Australia;The Mater Research Institute - The University of Queensland, Queensland, Australia;The Mater Research Institute - The University of Queensland, Queensland, Australia;The University of South Australia, Adelaide, Australia;Women and Children’s Hospital, Adelaide, Australia;The University of South Australia, Adelaide, Australia;

关键词: Intelligence;    Neurocognition;    Pre-school;    Child;    Sleep disordered breathing;    Tonsillectomy;    Adenotonsillectomy;    Clinical trial;   

DOI  :  10.1186/s12887-016-0758-8

 received in 2016-08-25, accepted in 2016-12-09,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundIQ 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.MethodsThis 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.DiscussionIf 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 registrationAustralian and New Zealand Clinical Trials Registration Number ACTRN12611000021976.

【 授权许可】

CC BY   
© The Author(s). 2017