Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000119291
Ethics application status
Approved
Date submitted
13/12/2017
Date registered
29/01/2018
Date last updated
20/01/2020
Date data sharing statement initially provided
20/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
PreEMPT: Preterm infant Early intervention for Movement and Participation Trial - how well does very early physiotherapy help infants to move and participate in everyday life? A feasibility trial
Scientific title
PreEMPT: Preterm infant Early intervention for Movement and Participation Trial – an assessor blinded randomised control pilot trial investigating the feasibility and efficacy of infant participation-focused physiotherapy on infant motor performance and participation.
Secondary ID [1] 293340 0
Nil known
Universal Trial Number (UTN)
U1111-1204-9322
Trial acronym
PreEMPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm infants 305434 0
Development 305435 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304711 304711 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 299594 0
Rehabilitation
Comparator / control treatment
Standard Physiotherapy Care
Standard care describes the typical physiotherapy intervention that a term to 4 month corrected age infant would receive at Toowoomba Hospital.

The purpose of standard physiotherapy care is to provide consistent set of appointments to assess a preterm infant’s neurodevelopment. The content of standard care sessions is variable according to clinician expertise and training, though it typically consists of developmental (neuro, sensory, motor) assessments with ideas regarding positioning and handling provided for home practice given to the family.
Standard care is currently delivered via two to three 45 min face-to-face sessions between 0-4 months corrected age (typically close to 2, 12 and 14 weeks corrected age - corrected for the infant’s prematurity).
Standard care physiotherapy will be delivered by a physiotherapist employed by Toowoomba Hospital (who is not the PreEMPT physiotherapist or blinded assessing physiotherapist) in the physiotherapy outpatient clinic setting at Toowoomba Hospital. A chart audit will be undertaken to evaluate the content, dose and frequency of standard care at the completion of the study, and a random selection of sessions will be videoed and coded for content.
Control group
Active

Outcomes
Primary outcome [1] 303920 0
Test of Infant Motor Performance (TIMP)
Timepoint [1] 303920 0
4 months corrected age
Secondary outcome [1] 340462 0
Alberta Infant Motor Scale (AIMS)
Timepoint [1] 340462 0
4, 6 and 8 months corrected age
Secondary outcome [2] 340463 0
Neuro-Sensory Motor Developmental Assessment (NSMDA)
Timepoint [2] 340463 0
4 and 8 months corrected age
Secondary outcome [3] 340481 0
Daily Activities of Infants Scale (DAIS)
Timepoint [3] 340481 0
4, 6 and 8 months corrected age
Secondary outcome [4] 340482 0
Infant Participation Questionnaire (designed specifically for this study)
Timepoint [4] 340482 0
4, 6, and 8 months corrected age
Secondary outcome [5] 340483 0
Cognitive domain - Bayley Scales of Infant and Toddler Development 3rd Edition (BSITD-3)
Timepoint [5] 340483 0
8 months corrected age
Secondary outcome [6] 340484 0
Language domain - Bayley Scales of Infant and Toddler Development 3rd Edition (BSITD-3)
Timepoint [6] 340484 0
8 months corrected age
Secondary outcome [7] 341209 0
Motor domain - Bayley Scales of Infant and Toddler Development 3rd Edition (BSITD-3)
Timepoint [7] 341209 0
8 months corrected age
Secondary outcome [8] 341210 0
Service satisfaction survey (specifically designed for this study) - parents
Timepoint [8] 341210 0
4 months corrected age
Secondary outcome [9] 341647 0
Hospital Anxiety and Depression Scale (HADS) - parents
Timepoint [9] 341647 0
4 and 8 months
Secondary outcome [10] 341648 0
Parental Sense of Competence Scale (PSCS) - parents
Timepoint [10] 341648 0
4 and 8 months

Eligibility
Key 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.
Minimum age
0 Months
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

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)
Following determination of eligibility and gaining informed consent, infants will undergo baseline motor assessment. Outcomes of the baseline motor assessment will be used to stratify infants prior to randomisation according to the categories below. This will be performed to promote more even distribution of baseline motor abilities of infants in the Standard Physiotherapy Care versus PreEMPT Physiotherapy groups.

- High risk for motor difficulties - Infants who show ‘abnormal’ writhing movements on the General Movements Assessment AND/OR score less than the 16th centile (-1 standard deviation) on the Test of Infant Motor Performance (TIMP) at T1 (0m)

- Low risk for motor difficulties - Infants who show ‘normal’ writhing movements on the GMs and score between the 16-100th centiles on the TIMP at T1 (0m).

After stratification, infants will be randomly assigned to intervention arms using pre-prepared sealed opaque envelopes containing randomly generated numbers (1,2) to represent Standard Physiotherapy Care or PreEMPT Physiotherapy groups.

Infants who are part of a multiple birth group (i.e. twins, triplets etc) will be randomised to the same intervention arm as the oldest sibling in the birth group.

Infants of families who provide consent to participate will be randomly assigned to intervention arms using pre-prepared sealed opaque envelopes containing randomly generated numbers (1,2) to represent PreEMPT or standard care physiotherapy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation concealment will be achieved by
- A sequence of random numbers (1 or 2) will be generated by a researcher in the Children’s Motor Control Research Collaboration group at The University of Queensland who is not involved in the study design nor assessment or treatment of infants in the study. Each number will be printed onto separate and subsequent pieces of paper.
- One sequence of numbers will be generated for each stratification group. The numbered pages will be concealed in opaque envelopes and stored in the designated order by the researcher at The University of Queensland.
- At the time of randomisation of each infant, CIA Mobbs will contact the researcher who will open the next available envelope relevant to the infant’s stratification group and read out the treatment arm allocation
- The infant will then proceed to take part in the study in that study arm
- At no time will the assessing physiotherapist/s have any knowledge of treatment group allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed by the chief investigator using SPSS statistical software. Primary analysis will use the intention to treat principle, using the last observation recorded for participants who withdraw from the program.

Assessment results will be used to evaluate change pre and post intervention (Test of Infant Motor Performance) and compare between groups differences (all other assessments). As no studies to date have explored the relationship between motor performance and participation in preterm infants, results from the Test of Infant Motor Performance, Alberta Infant Motor Scale, Neuro-Sensory Motor Developmental Assessment and Bayley Scales of Infant and Toddler Development will be compared to the responses identified in semi-structured interviews using the Daily Activities of Infants Scale and a infant participation questionnaire encompassing the key components of participation - "attendance" (measured as diversity and frequency) and "involvement" in daily life situations. For continuous and categorical variables, outcomes between groups were analyzed using linear and logistic regression, respectively. Models will be fitted using generalized estimating equations (GEEs) with an exchangeable correlations structure and robust standard errors to allow for correlations between twins in the study for child outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2018
Actual
30/01/2018
Date of last participant enrolment
Anticipated
Actual
31/08/2018
Date of last data collection
Anticipated
Actual
6/06/2019
Sample size
Target
20
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9382 0
Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 18077 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 297962 0
Government body
Name [1] 297962 0
Australian Government Research Training Program Scholarship
Country [1] 297962 0
Australia
Funding source category [2] 297971 0
Charities/Societies/Foundations
Name [2] 297971 0
Children’s Hospital Foundation PhD Top-up Scholarship
Country [2] 297971 0
Australia
Funding source category [3] 297972 0
Government body
Name [3] 297972 0
Queensland Health - Health Practitioner Research Scheme
Country [3] 297972 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Qld 4072
Country
Australia
Secondary sponsor category [1] 297025 0
Hospital
Name [1] 297025 0
Toowoomba Hospital
Address [1] 297025 0
Toowoomba Hospital
Darling Downs Hospital and Health Service
154 Pechey Street
Toowoomba Qld 4350
Country [1] 297025 0
Australia
Other collaborator category [1] 279798 0
University
Name [1] 279798 0
University of Melbourne
Address [1] 279798 0
School of Physiotherapy
The University of Melbourne
Victoria 3010
Country [1] 279798 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299003 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 299003 0
Ethics committee country [1] 299003 0
Australia
Date submitted for ethics approval [1] 299003 0
17/07/2017
Approval date [1] 299003 0
21/08/2017
Ethics approval number [1] 299003 0
HREC/17/QRCH/165
Ethics committee name [2] 299011 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 299011 0
Ethics committee country [2] 299011 0
Australia
Date submitted for ethics approval [2] 299011 0
22/08/2017
Approval date [2] 299011 0
27/09/2017
Ethics approval number [2] 299011 0
2017001294

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78966 0
Ms Chelsea Mobbs
Address 78966 0
The School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia Qld 4072
Country 78966 0
Australia
Phone 78966 0
+61 408889373
Fax 78966 0
Email 78966 0
[email protected]
Contact person for public queries
Name 78967 0
Chelsea Mobbs
Address 78967 0
The School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia Qld 4072
Country 78967 0
Australia
Phone 78967 0
+61 408889373
Fax 78967 0
Email 78967 0
[email protected]
Contact person for scientific queries
Name 78968 0
Chelsea Mobbs
Address 78968 0
The School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia Qld 4072
Country 78968 0
Australia
Phone 78968 0
+61 408889373
Fax 78968 0
Email 78968 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6480Study protocol    Study protocol will be available once data analysi... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePreEMPT (Preterm infant Early intervention for Movement and Participation Trial): Feasibility outcomes of a randomised controlled trial.2022https://dx.doi.org/10.1016/j.earlhumdev.2022.105551
N.B. These documents automatically identified may not have been verified by the study sponsor.