None listed
Conditions
Brief summary
This pilot study aims to determine the feasibility of a randomised controlled clinical trial (RCT) of Supporting Early Play Exploration and Early Development Intervention (SPEEDI) for preterm infants, to inform a larger RCT. SPEEDI focuses on early motor development, environmental enrichment and supporting parent infant interaction. It involves direct physiotherapy/ occupational therapy and parent provided activities, with 5 sessions delivered in the neonatal nursery, and 5 in the home setting, until 3 months’ corrected age. Twenty infants born <30 weeks’ gestation will be recruited from The Royal Women’s Hospital. After baseline assessment at 34-38 weeks’ corrected age, infants will be randomly assigned to SPEEDI or usual care. At 3 and 4 months’ corrected age infants will be assessed using standardised measures of motor function and cognitive skills by assessors blind to infant group allocation. Parents in both groups will be interviewed about their experience of the study. Primary outcome is study feasibility (including enrolment and attrition rates), acceptability (participant experience and willingness to be randomised), and standard deviations of the outcome measures to estimate sample size for a larger RCT
Interventions
The SPEEDI intervention consists of two phases. Phase 1: commences in the neonatal nursery environment when the infant is medically stable (according to the medical team). During this phase, a physiotherapist/occupational therapist will meet with the parent 2-5 times to deliver education on the SPEEDI intervention. The SPEEDI intervention focuses on supporting parents to play with their infants, encourages activate infant movement, environmental enrichment and positive interactions to improve motor and cognitive development. Parent education will be provided by the physiotherapist/occupational therapist during the infant’s stay in neonatal nursery and continue at home if the infant is discharged home prior to term equivalent age. Topics will be centred around promoting development and the goals of the SPEEDI intervention (i.e. supporting play exploration and early development of motor skills such as head control, reaching and rolling), as well as demonstration of intervention activities. Parents will be supported to complete movement activities with their child, the aim of which are to allow the infant to experience self-directed and variable movements and explore social interactions. Prior to discharge from the neonatal nursery, parents will be provided with an education booklet (SPEEDI Activity Booklet) detailing intervention activities that can be completed at home, with accompanying pictures. The infant will need to be an inpatient at the Royal Women’s Hospital for the baseline assessment and first two intervention session. Parent education sessions in phase 1 will be from 15-45 minutes, depending on the infant and parent/s' needs. Phase 2: begins when Phase 1 has been completed and continues until the infant is 3 months’ corrected age. Phase 2 will involve parental interaction with their child in the home setting, aiming for minimum of 20 minutes per day, 5 times per week of intervention activities delivered by parents. Parents will be encouraged to establish a routine for developmental play, including recognising when their child is ready to socially interact and their child’s responses to interactions. Parents will complete a daily activity log, indicating which developmental activities they worked on each day. A physiotherapist/occupational therapist will meet with the parent and infant regularly, completing 5 visits in total, until the infant is 3 months’ corrected age. These sessions will allow parents to ask questions, and for the developmental activities to be progressed. Each infant will receive 5 therapy sessions at home with a focus on advancing the parent provided interventions, which will be 30-60 minutes in duration depending on the infant and parent/s needs. On average the visits are every 2.5 weeks – 5 visits over 12 weeks.
Sponsors
Study design
Eligibility
Inclusion criteria
Infants born <30 weeks’ gestation and admitted to the Royal Women’s Hospital will be eligible for recruitment. Infants must be an inpatient at the Royal Women’s at time of recruitment. Eligibility criteria: Infants must be medically stable and off ventilator support at time of recruitment. Infants may be receiving other respiratory support such as CPAP (continuous positive airway pressure) or nasal high-flow. Infants must live within 30 kilometres travel distance of the Royal Women’s Hospital (due to home visits), and at least one caregiver must speak English.
Exclusion criteria
Infants will be excluded if they have a diagnosis of a genetic syndrome or musculoskeletal deformity.