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Trial registered on ANZCTR


Registration number
ACTRN12618001305213
Ethics application status
Approved
Date submitted
31/07/2018
Date registered
2/08/2018
Date last updated
24/07/2019
Date data sharing statement initially provided
24/07/2019
Date results information initially provided
24/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Supporting Play Exploration and Early Developmental Intervention (SPEEDI) for Preterm Infants - Feasibility Study
Scientific title
Supporting Play Exploration and Early Developmental Intervention (SPEEDI) for Preterm Infants - Feasibility Study
Secondary ID [1] 295708 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SPEEDI – feasibility study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm neurodevelopment 309102 0
motor impairment 309103 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307979 307979 0 0
Physiotherapy
Physical Medicine / Rehabilitation 307980 307980 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 302030 0
Rehabilitation
Intervention code [2] 302031 0
Prevention
Comparator / control treatment
Infants that are randomised to the non-intervention group will receive usual care from the neonatal allied health team at the Royal Women's Hospital who see preterm infants that are born <28 weeks’ gestational age and/or <1000g birthweight. Usual care includes education regarding neurodevelopment (such as written handouts on aspects of preterm development, individualised developmental care plans), and neurobehavioural assessment at term-equivalent age. Infants will be referred to developmental follow-up services after discharge from the Royal Women’s Hospital as per usual care; this may include community-based early intervention services or referral to the allied health follow-up clinic at the Royal Women’s Hospital.
Control group
Active

Outcomes
Primary outcome [1] 306955 0
The primary outcome is establish feasibility. Study enrolment and attrition rates will be collected to determine the feasibility of completing the SPEEDI intervention approach. An activity log will be used to determine the frequency of therapist intervention (phase 1), parent education sessions (phase 1) and parent-delivered intervention (phase 2).
Timepoint [1] 306955 0
4 months' corrected age
Secondary outcome [1] 350220 0
1. Trial acceptability: Parents will participate in a guided interview at the completion of the study. Guided, open-ended questions will be based upon those used in the USA SPEEDI feasibility trial, to elicit feedback on parent perception of the study.
Timepoint [1] 350220 0
4 months' corrected age
Secondary outcome [2] 350221 0
2. The Test of Infant Motor Performance (TIMP): is a neuromotor developmental assessment for infants between 34 weeks post-menstrual age and 4 months (corrected age), and will be administered at 3 timepoints (baseline, 3 and 4 months’ corrected age).
Timepoint [2] 350221 0
3 and 4 months' corrected age
Secondary outcome [3] 350222 0
3. The General Movement Assessment (GMA): assesses the quality of an infant’s spontaneous movement from birth to 20 weeks’ corrected age. The GMA is predictive of motor outcomes, including CP and will be used at baseline, 3 and 4 months’ corrected age.
Timepoint [3] 350222 0
3 and 4 months' corrected age
Secondary outcome [4] 350223 0

4.The Bayley Scales of Infant and Toddler Development- 3rd Edition (Bayley-III): is a norm-referenced developmental scale of cognitive, language and motor development that has good psychometric properties, and has been used extensively in follow-up of preterm infants. The Bayley-III will be administered at 4 months’ corrected age.
Timepoint [4] 350223 0
4 months' corrected age
Secondary outcome [5] 350224 0
5. Early Problem Solving Indicator (EPSI): is a component of the Individual Growth and Development Indicators that measures cognition using a play-based problem solving assessment.
Timepoint [5] 350224 0
4 months' corrected age

Eligibility
Key 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.
Minimum age
32 Weeks
Maximum age
38 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants will be excluded if they have a diagnosis of a genetic syndrome or musculoskeletal deformity.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation will be determined using concealed envelopes, labelled with sequential numbers in each strata (singleton vs multiple birth).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation will be computer generated by an independent statistician stratified for multiple births (singleton vs multiple birth).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Feasibility study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to assess participant characteristics, recruitment rates of infants, and number of infants who participated in each stage of the study.
Results of all outcome measures at each data collection point, for both intervention and control group, will be described using descriptive statistics.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/07/2018
Date of last participant enrolment
Anticipated
30/11/2018
Actual
13/11/2018
Date of last data collection
Anticipated
31/05/2019
Actual
16/07/2019
Sample size
Target
20
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11557 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 23585 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 300298 0
University
Name [1] 300298 0
The University of Melbourne
Country [1] 300298 0
Australia
Funding source category [2] 300299 0
Hospital
Name [2] 300299 0
The Royal Women's Hospital
Country [2] 300299 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
7th Floor, 161 Barry Street, Parkville, Victoria, Australia, 3052
Country
Australia
Secondary sponsor category [1] 299732 0
Hospital
Name [1] 299732 0
The Royal Women's Hospital
Address [1] 299732 0
Cnr Grattan Street and Flemington Parade, Parkville,Victoria, Australia, 3052
Country [1] 299732 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301110 0
The Royal Women's Hospital Research and Human Ethics Committee (EC00259)
Ethics committee address [1] 301110 0
Cnr Grattan Street and Flemington Road, Parkville Victoria, Australia, 3052
Ethics committee country [1] 301110 0
Australia
Date submitted for ethics approval [1] 301110 0
30/04/2018
Approval date [1] 301110 0
03/07/2018
Ethics approval number [1] 301110 0
Project 18/09

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85898 0
A/Prof Alicia Spittle
Address 85898 0
Department of Physiotherapy, The University of Melbourne, 7th Floor, 161 Barry Street, Parkville, Victoria, Australia, 3052
Country 85898 0
Australia
Phone 85898 0
+61390355390
Fax 85898 0
Email 85898 0
aspittle@unimelb.edu.au
Contact person for public queries
Name 85899 0
A/Prof Alicia Spittle
Address 85899 0
Department of Physiotherapy, The University of Melbourne, 7th Floor, 161 Barry Street, Parkville, Victoria, Australia, 3052
Country 85899 0
Australia
Phone 85899 0
+61390355390
Fax 85899 0
Email 85899 0
aspittle@unimelb.edu.au
Contact person for scientific queries
Name 85900 0
A/Prof Alicia Spittle
Address 85900 0
Department of Physiotherapy, The University of Melbourne, 7th Floor, 161 Barry Street, Parkville, Victoria, Australia, 3052
Country 85900 0
Australia
Phone 85900 0
+61390355390
Fax 85900 0
Email 85900 0
aspittle@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We don't have ethics for this


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3386Ethical approval  aspittle@unimelb.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSupporting Play, Exploration, and Early Development Intervention (SPEEDI) for preterm infants: A feasibility randomised controlled trial in an Australian context.2020https://dx.doi.org/10.1016/j.earlhumdev.2020.105172
N.B. These documents automatically identified may not have been verified by the study sponsor.