None listed
Conditions
Brief summary
Each year, approximately 24,000 infants are born prematurely in Australia, with approximately 3,500 of these infants residing in regional and remote locations. Research has identified that infants born prematurely are more likely to experience developmental delay and disability compared to their term born peers. The evidence for early intervention to improve motor and cognitive outcomes for preterm infants prior to preschool age is growing, however more research is needed to understand the most effective dosage, timing and content of such therapy. Even less understood is the impact of early intervention for preterm infants on their participation. The aim of the new PreEMPT Physiotherapy Program is to enhance Standard Physiotherapy Care in the first four months post term corrected age via 3 key aspects: - Participation-focused: PreEMPT has been designed to put the focus on participation of the infant within the context of their family. Life situations important to the family will be identified by the family at the start of each PreEMPT session, and will be used as a starting point to drill down to the sensorimotor capabilities needed to participate in these identified life situations. - Enablement-model - PreEMPT focuses on an enablement model with parents/care-givers to facilitate goal-setting and take a solution-focused approach to supporting their infant’s development in the context of their unique family circumstances. - Mix service delivery model of face to face and telehealth: Telehealth has been used across a variety of adult and paediatric populations to support the health and rehabilitation of those who reside in regional and remote areas, however there are no current studies published that incorporate telehealth-based physiotherapy services for preterm infants. Telehealth will be used to provide more regular opportunities for checking development, for progressing intervention, and for supporting parent enablement in the first 4 months post term age. 20 infants will be recruited. Following consent and baseline assessment at term corrected age, infants will be randomised to either Standard Physiotherapy Care (SPC) (n=10) or PreEMPT Physiotherapy (n=10). Infants randomised to SPC will receive 3 physiotherapy sessions consisting of general information regarding physical develop as is the current practice at Toowoomba Hospital. Infants randomised to the PreEMPT arm will receive alternating face to face (total = 7) and telehealth (total=7) weekly from 2 -15 weeks corrected age. The primary aim is to evaluate the feasibility and efficacy in improving motor performance of infants at 4 months corrected age. Secondary aims include exploring the relationship between motor performance and participation, evaluating the effectiveness of PreEMPT on an infant’s General Movements, and on an infant’s language, motor, and cognitive development and finally to evaluate the impact of PreEMPT on parental mental well-being and satisfaction.
Interventions
PreEMPT intervention
PreEMPT is a participation-focused physiotherapy intervention that incorporates strategies from across the ICF to support an infant’s participation within the context of their family. Intervention priorities are driven by collaborative goal setting with parents, and a strengths-based approach is used throughout assessment and intervention to build the capacity of the parent. Assessment includes task and environment analysis, as well as evaluation of necessary neuro-sensory-
PreEMPT intervention PreEMPT is a participation-focused physiotherapy intervention that incorporates strategies from across the ICF to support an infant’s participation within the context of their family. Intervention priorities are driven by collaborative goal setting with parents, and a strengths-based approach is used throughout assessment and intervention to build the capacity of the parent. Assessment includes task and environment analysis, as well as evaluation of necessary neuro-sensory-motor abilities required for participation. Physical, social or environmental strategies are selected relevant to achieving a chosen participation goal. Intervention is delivered using a combination of clinic-based face-to-face sessions for physical skills teaching and telehealth-based consultations to assist with task and environment modifications to support the child and parent at home Therapy sessions will be structured as followed: 1. GOAL SETTING (10min) - to identify aspects of their infant’s participation in everyday life situations they would like support with. 2. ASSESS (10min) – to analyse the key components of the life situation identified by the family. This may include the infant’s activity competence and body structure and function integrities, environment and participation-related aspects of functional performance. 3. TRAIN (15 min) – Identifying, trialling and practicing intervention strategies pitched at the “just right” challenge for the infant using infant cues to modify the difficulty of the intervention as needed. 4. TRANSLATE (10min) – solution-focused discussion with the family to identify ways the new strategies identified can be integrated into every day life situations. Personalised home programs will be provided. Pre-EMPT will include a combination of hospital-based face-to-face sessions and home-based telehealth sessions. Face-to-face sessions will be provided in a standard outpatient clinic setting of a hospital. Telehealth sessions will be led at the Physiotherapist’s end from the hospital outpatient department and received at the family’s end via a home-based video call. PreEMPT will be delivered over 14 sessions (7 face-to-face and 7 tele-health) alternating weekly from 2 weeks corrected age to 15 weeks corrected age. Face-to-face – twice per month up to 3.5 months (at 2,4,6,8,10,12 and 14 weeks) corrected age (i.e. from the infant’s intended due date) Telehealth – twice per month up to 3.5 months (at 3,5,7,9,11 and 13 weeks) corrected age The duration of each session will be 45 minutes. To enhance fidelity, the treating physiotherapist delivering PreEMPT will be consistent through the duration of the study. Individual treatment session content will be recorded and a random sample of sessions will be video analysed by two members of the research team to code the content of the session. Parents will be asked to keep a record of home activities practiced.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 4 Months
Healthy volunteers
No
Inclusion criteria
Infants will be eligible to participate in the study if they are: 1. Were born preterm (i.e. at or less than 34 weeks and six days gestation) 2. Have at least one parent/guardian who speaks English well enough to enable telehealth-based service delivery 3. Are able to attend three 1 hour assessments during the 16-week follow up phase irrespective of group allocation. 4. Are able to attend an additional seven 45 min face-to-face appointments and seven 45 min telehealth appointments over the 16-week intervention phase if randomised to the PreEMPT Physiotherapy group.
Exclusion criteria
Infants will be excluded if they: • Are diagnosed with a medical or behavioural condition known to impact development over and above being born pre-term (e.g. a genetic syndrome such as Down Syndrome)
Outcome results
None listed