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Protocol for a multisite randomised controlled trial assessing the effect of the Telehealth for Early Developmental
Abbey L Eeles1,2,3, Alicia J Spittle4,2,3, Stacey Dusing5
1Department of Physiotherapy, University of Melbourne, Melbourne, Victoria, Australia abbey.eeles@unimelb.edu.au.
Insights
This study evaluates the TEDI-Prem telehealth intervention for very preterm infants, aiming to improve neurodevelopmental outcomes and parental well-being. Results will inform early intervention strategies for this vulnerable population.
Area of Science:
- Neonatal Medicine
- Developmental Pediatrics
- Digital Health Interventions
Background:
- Infants born very preterm (<32 weeks' gestation) face heightened risks of neurodevelopmental impairments and behavioral delays.
- Parents of very preterm infants often experience poorer mental health outcomes compared to parents of full-term infants.
- Existing research highlights the need for effective early developmental interventions for very preterm infants and their families.
Purpose of the Study:
- To determine the efficacy of the TEDI-Prem (Telehealth for Early Developmental Intervention in babies born very preterm) program.
- To assess the impact of TEDI-Prem on neurodevelopmental outcomes and parental well-being in very preterm infants.
- To compare TEDI-Prem plus usual care against usual care alone in a randomized controlled trial.
Main Methods:
- A multicentre, pragmatic, parallel-group, randomized controlled trial involving 466 very preterm infants across five Australian hospitals.
- Participants randomized to either TEDI-Prem plus usual care or usual care alone.
- TEDI-Prem intervention includes 13 sessions (face-to-face and telehealth) until 12 months corrected age, focusing on motor, cognitive, and language development, parent-child interaction, and parental mental health.
Main Results:
- Primary outcome: Bayley Scales of Infant and Toddler Development-fourth edition (Bayley-4) Motor Composite Score at 12 months corrected age.
- Secondary outcomes include cognitive and language scores, social-emotional assessment, parental mental health, parent-child interaction, and quality of life measures at 12 and 24 months corrected age.
- Statistical analysis using linear and logistic regression via generalized estimating equations to account for multiple births and site effects.
Conclusions:
- The TEDI-Prem intervention is hypothesized to improve neurodevelopmental outcomes and parental well-being in very preterm infants.
- Findings will provide evidence on the effectiveness of telehealth-based early developmental interventions for this high-risk population.
- Results will inform clinical practice and policy regarding early intervention services for infants born very preterm.
Introduction:
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.
Methods And Analysis:
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.
Ethics And Dissemination:
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.
Trial Egistration Number:
This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12621000364875).
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