Eeles Abbey L, Spittle Alicia J, Dusing Stacey, Anderson Peter J, Brown Shaaron, Dalziel Kim, Fehring Susan M, Henty Gillian, Holland Anne E, Huang Li, Hunt Rod W, Kozaris Elizabeth, Lee Katherine, Morgan Angela T, Schembri Rachel, Treyvaud Karli
Department of Physiotherapy, University of Melbourne, Melbourne, Victoria, Australia
Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
BMJ Open. 2024 Dec 20;14(12):e086904. doi: 10.1136/bmjopen-2024-086904.
Infants born very preterm (VPT, <32 weeks' gestation) are at increased risk for neurodevelopmental impairments including motor, cognitive and behavioural delay. Parents of infants born VPT also have poorer mental health outcomes compared with parents of infants born at term.We have developed an intervention programme called TEDI-Prem (Telehealth for Early Developmental Intervention in babies born very preterm) based on previous research. TEDI-Prem aims to improve neurodevelopmental outcomes and parental well-being in children born VPT. Here we present the protocol outlining a multicentre, pragmatic, parallel-group, randomised controlled trial to determine the efficacy of TEDI-Prem plus usual care, compared with usual care alone.
We will recruit 466 VPT infants from the neonatal units of five hospitals in Victoria, Australia. Participants will be randomised, stratified by site of recruitment and multiple births, to TEDI-Prem plus usual care or usual care alone. The TEDI-Prem intervention programme involves 13 sessions across three phases. Phase 1 commences in the neonatal unit with four face-to-face sessions with parent/s and a physiotherapist/occupational therapist. Once discharged from the hospital, sessions across phases 2 and 3 (six and three sessions, respectively) continue via telehealth until infants are 12 months' corrected age (CA).The primary outcome is the Bayley Scales of Infant and Toddler Development-fourth edition (Bayley-4) Motor Composite Score at 12 months' CA. Secondary outcomes address other neurodevelopmental domains (Bayley-4 cognitive and language composite score; Infant Toddler Social Emotional Assessment), parental mental health (Depression Anxiety and Stress Scale 21), parent-child interaction (Emotional Availability Scale) and programme cost-effectiveness which encompasses parent quality of life (Short-Form Six-Dimension Quality of Life) and child quality of life (EuroQol Toddler and Infant Populations measure) at 12 and 24 months' CA.Mean differences between groups will be examined using linear regression for continuous outcomes and logistic regression for binary outcomes. All models will be fitted via generalised estimating equations to account for multiple births and adjusted for the hospital sites.
This trial has Royal Children's Hospital Human Research and Ethics Committee approval (HREC/67604/RCHM-2020) with specific site approval for all participating sites. Findings will be disseminated through peer-reviewed publications, conference presentations, digital and print media and to participants.
This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12621000364875).
极早产儿（VPT，妊娠<32周）患神经发育障碍的风险增加，包括运动、认知和行为发育迟缓。与足月儿的父母相比，极早产儿的父母心理健康状况也较差。基于之前的研究，我们开发了一个名为TEDI-Prem（极早产儿早期发育干预远程医疗）的干预项目。TEDI-Prem旨在改善极早产儿的神经发育结局和父母的幸福感。在此，我们展示了一项多中心、实用、平行组、随机对照试验的方案，以确定TEDI-Prem加常规护理与单纯常规护理相比的疗效。
我们将从澳大利亚维多利亚州五家医院的新生儿病房招募466名极早产儿。参与者将按招募地点和多胞胎进行分层随机分组，分为TEDI-Prem加常规护理组或单纯常规护理组。TEDI-Prem干预项目包括三个阶段的13次课程。第一阶段在新生儿病房开始，与父母和物理治疗师/职业治疗师进行4次面对面课程。出院后，第二阶段和第三阶段的课程（分别为6次和3次）通过远程医疗继续进行，直到婴儿达到12个月矫正年龄（CA）。主要结局是12个月矫正年龄时的贝利婴幼儿发展量表第四版（Bayley-4）运动综合评分。次要结局涉及其他神经发育领域（Bayley-4认知和语言综合评分；婴幼儿社会情感评估）、父母心理健康（抑郁焦虑压力量表21）、亲子互动（情感可及性量表）以及项目成本效益，其中包括12个月和24个月矫正年龄时的父母生活质量（简短形式六维度生活质量）和儿童生活质量（欧洲生活质量量表婴幼儿版）。对于连续结局，将使用线性回归分析组间均值差异；对于二元结局，将使用逻辑回归分析。所有模型将通过广义估计方程进行拟合，以考虑多胞胎情况，并对医院地点进行调整。
本试验已获得皇家儿童医院人类研究与伦理委员会批准（HREC/67604/RCHM - 2020），所有参与地点均获得特定地点批准。研究结果将通过同行评审出版物、会议报告、数字和印刷媒体以及向参与者进行传播。
本试验已在澳大利亚新西兰临床试验注册中心注册（ACTRN12621000364875）。
