ANZCTR - Registration

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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]

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

Development

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

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]

Test of Infant Motor Performance (TIMP)

Timepoint [1]

4 months corrected age

Secondary outcome [1]

Alberta Infant Motor Scale (AIMS)

Timepoint [1]

4, 6 and 8 months corrected age

Secondary outcome [2]

Neuro-Sensory Motor Developmental Assessment (NSMDA)

Timepoint [2]

4 and 8 months corrected age

Secondary outcome [3]

Daily Activities of Infants Scale (DAIS)

Timepoint [3]

4, 6 and 8 months corrected age

Secondary outcome [4]

Infant Participation Questionnaire (designed specifically for this study)

Timepoint [4]

4, 6, and 8 months corrected age

Secondary outcome [5]

Cognitive domain - Bayley Scales of Infant and Toddler Development 3rd Edition (BSITD-3)

Timepoint [5]

8 months corrected age

Secondary outcome [6]

Language domain - Bayley Scales of Infant and Toddler Development 3rd Edition (BSITD-3)

Timepoint [6]

8 months corrected age

Secondary outcome [7]

Motor domain - Bayley Scales of Infant and Toddler Development 3rd Edition (BSITD-3)

Timepoint [7]

8 months corrected age

Secondary outcome [8]

Service satisfaction survey (specifically designed for this study) - parents

Timepoint [8]

4 months corrected age

Secondary outcome [9]

Hospital Anxiety and Depression Scale (HADS) - parents

Timepoint [9]

4 and 8 months

Secondary outcome [10]

Parental Sense of Competence Scale (PSCS) - parents

Timepoint [10]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Toowoomba Hospital - Toowoomba

Recruitment postcode(s) [1]

4350 - Toowoomba

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Research Training Program Scholarship

Address [1]

Department of Education and Training
GPO Box 9880
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Children’s Hospital Foundation PhD Top-up Scholarship

Address [2]

Children’s Hospital Foundation
PO Box 8009
Woolloongabba QLD 4102

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

Queensland Health - Health Practitioner Research Scheme

Address [3]

Department of Health
Allied Health Professions' Office of Queensland
PO Box 2368
Fortitude Valley BC Qld 4006

Country [3]

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]

Hospital

Name [1]

Toowoomba Hospital

Address [1]

Toowoomba Hospital
Darling Downs Hospital and Health Service
154 Pechey Street
Toowoomba Qld 4350

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

University of Melbourne

Address [1]

School of Physiotherapy
The University of Melbourne
Victoria 3010

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Health Queensland Hospital and Health Service Human Research Ethics Committee

Ethics committee address [1]

Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street, South Brisbane  QLD  4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/07/2017

Approval date [1]

21/08/2017

Ethics approval number [1]

HREC/17/QRCH/165

Ethics committee name [2]

The University of Queensland Human Research Ethics Committee

Ethics committee address [2]

The University of Queensland 
St Lucia Qld 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

22/08/2017

Approval date [2]

27/09/2017

Ethics approval number [2]

2017001294

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Chelsea Mobbs

Address

The School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia Qld 4072

Country

Australia

Phone

+61 408889373

Fax

c.mobbs@uqconnect.edu.au

Contact person for public queries

Name

Chelsea Mobbs

Address

The School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia Qld 4072

Country

Australia

Phone

+61 408889373

Fax

c.mobbs@uqconnect.edu.au

Contact person for scientific queries

Name

Chelsea Mobbs

Address

The School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia Qld 4072

Country

Australia

Phone

+61 408889373

Fax

c.mobbs@uqconnect.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6480	Study protocol				Study protocol will be available once data analysi... [More Details]

Results publications and other study-related documents

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Documents added automatically

Source	Title	Year of Publication	DOI
Embase	PreEMPT (Preterm infant Early intervention for Movement and Participation Trial): Feasibility outcomes of a randomised controlled trial.	2022	https://dx.doi.org/10.1016/j.earlhumdev.2022.105551

N.B. These documents automatically identified may not have been verified by the study sponsor.

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