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随机分为早期神经保护和神经康复组:四项随机临床试验参与者的随访研究方案。

andomised to early neuroprotection and neurorehabilitation: protocol for a follow-up study of participants from four randomised clinical trials.

机构信息

Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia

Cerebral Palsy Alliance Research Institute, Specialty of Child & Adolescent Health, Sydney Medical School, Faculty of Medicine & Health, The University of Sydney, Sydney, New South Wales, Australia.

出版信息

BMJ Open. 2023 Feb 27;13(2):e068675. doi: 10.1136/bmjopen-2022-068675.

DOI:10.1136/bmjopen-2022-068675
PMID:36849209
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9972445/
Abstract

INTRODUCTION

School readiness includes cognitive, socio-emotional, language and physical growth and development domains which share strong associations with life-course opportunities. Children with cerebral palsy (CP) are at increased risk of poor school readiness compared with their typically developing peers. Recently, earlier diagnosis of CP has allowed interventions to commence sooner, harnessing neuroplasticity. First, we hypothesise that early referral to intervention for children at-risk of CP will lead to improved school readiness at 4-6 years relative to placebo or care as usual. Second, we hypothesise that receipt of early diagnosis and early intervention will lead to cost-savings in the form of reduced healthcare utilisation.

METHODS AND ANALYSIS

Infants identified as at-risk of CP ≤6 months corrected age (n=425) recruited to four randomised trials of neuroprotectants (n=1), early neurorehabilitation (n=2) or early parenting support (n=1) will be re-recruited to one overarching follow-up study at age 4-6 years 3 months. A comprehensive battery of standardised assessments and questionnaires will be administered to assess all domains of school readiness and associated risk factors. Participants will be compared with a historical control group of children (n=245) who were diagnosed with CP in their second year of life. Mixed-effects regression models will be used to compare school readiness outcomes between those referred for early intervention versus placebo/care-as-usual. We will also compare health-resource use associated with early diagnosis and intervention versus later diagnosis and intervention.

ETHICS AND DISSEMINATION

The Children's Health Queensland Hospital and Health Service, The University of Queensland, University of Sydney, Monash University and Curtin University Human Research Ethics Committees have approved this study. Informed consent will be sought from the parent or legal guardian of every child invited to participate. Results will be disseminated in peer-reviewed journals, scientific conferences and professional organisations, and to people with lived experience of CP and their families.

TRIAL REGISTRATION NUMBER

ACTRN12621001253897.

摘要

简介

学校准备包括认知、社会情感、语言和身体成长与发展领域,这些领域与人生机会密切相关。与正常发育的同龄人相比,脑瘫(CP)儿童在学校准备方面的风险更高。最近,CP 的早期诊断使得干预措施能够更早开始,利用神经可塑性。首先,我们假设对 CP 高危儿童的早期干预转诊将导致 4-6 岁时的学校准备情况相对安慰剂或常规护理得到改善。其次,我们假设早期诊断和早期干预的实施将减少医疗保健利用,从而节省成本。

方法和分析

在四项神经保护剂(n=1)、早期神经康复(n=2)或早期育儿支持(n=1)的随机试验中,≤6 个月矫正年龄(n=425)的被识别为 CP 高危婴儿将重新招募到一项为期 4-6 岁 3 个月的总体随访研究中。将对参与者进行全面的标准化评估和问卷调查,以评估学校准备的所有领域及其相关的危险因素。将参与者与在生命第二年被诊断为 CP 的 245 名历史对照组儿童进行比较。将使用混合效应回归模型比较早期干预转诊组与安慰剂/常规护理组之间的学校准备结果。我们还将比较与早期诊断和干预相关的健康资源利用与晚期诊断和干预的资源利用。

伦理和传播

昆士兰儿童健康医院和健康服务中心、昆士兰大学、悉尼大学、莫纳什大学和科廷大学人类研究伦理委员会已批准该研究。将向每一位受邀参与的儿童的父母或法定监护人征求知情同意。研究结果将在同行评议的期刊、科学会议和专业组织中发表,并传达给有 CP 经历的人和他们的家庭。

试验注册号

ACTRN12621001253897。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f13b/9972445/2ed2b2febe86/bmjopen-2022-068675f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f13b/9972445/2ed2b2febe86/bmjopen-2022-068675f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f13b/9972445/2ed2b2febe86/bmjopen-2022-068675f01.jpg

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