PreEMPT (Preterm infant Early intervention for Movement and Participation Trial): The feasibility of a Novel, Participation-focused Early Physiotherapy intervention supported by Telehealth in Regional Australia - A Protocol

PreEMPT (Preterm infant Early intervention for Movement and Participation Trial): The feasibility of a Novel, Participation-focused Early Physiotherapy intervention supported by Telehealth in Regional Australia - A Protocol

Background: Early intervention is beneficial for improving preterm infant motor and cognitive outcomes in early childhood; however, little is known about whether early intervention can influence a preterm infant’s participation. Additionally, many studies investigating the impact of early intervention for preterm infants have been conducted in large metropolitan centres, leaving preterm infants who reside in regional areas underrepresented in the literature to date. Consequentially, it is not yet known whether there are service delivery models, such as using telehealth as an adjunct to face-to-face intervention, that might cater to the needs of preterm infants residing outside metropolitan centres. PreEMPT (Preterm infant Early intervention for Movement and Participation Trial) is a novel early physiotherapy intervention that has been designed to use a participation goal-directed intervention approach via a mixture of face-to-face clinic sessions and telehealth sessions to improve the motor and participation outcomes of preterm born infants. Methods: This study aims to evaluate the feasibility of PreEMPT using an assessor-blinded, randomised controlled trial to compare PreEMPT to Usual Physiotherapy Care (UPC) for preterm infants residing in a regional Australian hospital catchment area. Twenty-six preterm infants (≤34 + 6 weeks gestational age) will be recruited prior to term corrected age from the special care nursery of a regional hospital. Following informed consent and baseline assessments, infants will be randomly allocated to receive either PreEMPT, a novel participation-focused early physiotherapy intervention delivered weekly for 14 forty-five-minute sessions alternating face-to-face sessions with telehealth into the infant’s home, or UPC, two - three physiotherapy sessions in the 4-month intervention period. Outcome measures relating to infant neuromotor development, motor performance, general development, and parental mental health and well-being will be assessed at 4-, 6- and 8-months corrected age. Feasibility will be evaluated by acceptability (parental satisfaction), demand and practicality (recruitment rate and telehealth session implementation), implementation (attendance at assessment and treatment sessions), and limited efficacy testing (comparing outcomes listed above for infants in PreEMPT and UPC). Discussion: This study will be the first of its kind to use the participation of preterm infants in meaningful life situations as the foundation for intervention delivered via alternating face-to-face clinic sessions with telehealth into the home. The feasibility of this approach will be evaluated and used to inform future iterations of research about PreEMPT’s efficacy for improving preterm infant motor and participation outcomes.