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Trial registered on ANZCTR


Registration number
ACTRN12619000847112
Ethics application status
Approved
Date submitted
30/04/2019
Date registered
14/06/2019
Date last updated
5/08/2022
Date data sharing statement initially provided
14/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Best Start Trial: early intervention physiotherapy to improve motor outcomes in infants at high risk of cerebral palsy or motor delay
Scientific title
Does parent administered physiotherapy delivered to preterm/term infants at high risk of CP or motor delay improve motor outcomes at 16 weeks corrected age compared to usual care?
Secondary ID [1] 295667 0
Nil known
Universal Trial Number (UTN)
U1111-1218-1382
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abnormal brain imaging findings 309015 0
Seizures 309016 0
Significant post-natal infections 309017 0
Chronic lung disease (CLD) who received post-natal dexamethasone 309018 0
Intra-uterine growth retardation (IUGR) less than or equal to the 3rd centile. 309019 0
Abnormal General Movements scored at term age. 309020 0
Term infants with hypoxic ischaemic encephalopathy (HIE) 309021 0
Prematurity les than or equal to 27+6 weeks gestational age 309022 0
Condition category
Condition code
Neurological 307914 307914 0 0
Other neurological disorders
Infection 307916 307916 0 0
Studies of infection and infectious agents
Respiratory 307917 307917 0 0
Other respiratory disorders / diseases
Musculoskeletal 307918 307918 0 0
Other muscular and skeletal disorders
Reproductive Health and Childbirth 311158 311158 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Best Start Intervention.
The essential elements of the experimental intervention include:
(i) Physiotherapy Motor Training. Following individualised assessment of the infant, motor goals are discussed with the parents including head control, orientation of movements to the midline and eye-hand co-ordination. From the assessment, the infant’s individual limitations to attaining these goals are explained. Training is designed for the infants individual needs to target goal achievement and to be parent-administered. Experimental care interventions will involve the infant actively and repeatedly practicing movements in response to a parent stimulus or toy that provokes intentional active movement to achieve early motor milestone goals. Emphasis is placed on providing optimal motor learning opportunities without tiring their infant. Parents will be educated on how to read their infants behavioural cues to prevent this. The earliest age infants will commence motor training is 34 weeks GA as this has been identified as a time when infants can comfortably tolerate short periods of motor learning without detriment. Infants will regularly be reassessed to inform the infants motor learning needs.

(ii) Parent Coaching in Motor Training:
In the NICU and SCN, parents are coached in how to provide short periods (ie 5 minutes maximum three times per day) of motor training in the infants care time ie 30 mins before a feed when nappy changes and other routine cares are performed. Coaching involves helping parents practice activities which illicit motor goals whilst maintaining awareness of their infant’s behavioural cues. Activities will be selected which best suit the parents’ abilities and the infants’ needs. Coaching is therefore parent responsive and aims to support and optimise parent mental health, empowerment and attachment. It is also adapted to the infant’s family’s culture, education and parenting style. Coaching sessions will occur 1-2 times per week as indicated. On discharge home, further parent coaching will be performed by the experimental care physiotherapist. This will occur through home visits, clinic appointments and Skype© sessions on fortnightly – monthly basis as indicated. The duration of motor therapy sessions provided at home initially is three times 10 minutes per day delivered when the infant is alert and awake. By 16 weeks corrected age each of the three sessions will increase from 10 to 20 minutes.

Handouts will be provided with photographs, illustrations and instructions to support the therapy content and dosage to be administered by the parent/caregiver. Contacts for the experimental care physiotherapists will be provided to assist with any queries external to coaching times.

(iii) Environment Enrichment
Strong evidence exists for the provision of environmental enrichment strategies to advance motor development which includes consideration of motor, cognitive, sensory and social domains. Experimental care incorporates each of these aspects as follows with modifications as pertinent between the hospital and home environment:
a) Physical environment: provision of physical supports to promote movement eg creating nests, use of a supportive baby chair (Fraser chair) and the use of activities and materials (baby play gym and initial baby toys such as rattles and rings) to entice desired movements
b) Cognitive environment: by encouraging early infant problem solving such as hand sucking to functionally self-settle
c) Sensory environment: by providing the best background for enhancing motor learning capacity considering timing of therapy delivery with sleep, feeding, oxygen requirements and pain management so that the infant is alert, settled and happily able to best engage.
d) Social environment: by coaching parents to be sensitive, responsive and communicative to infant cues.
The mechanism of home visits will enable environmental enrichment strategies to be set up in the natural home environment through parent coaching. As this is where the majority of the experimental care interventions will occur, this will enable the translation of practice with is specific, relevant and at the appropriate intensity for the infant to achieve identified motor goals. Prior to discharge home, when the infant is still admitted in the NICU, efforts will be made to enrich the infant’s environment as much as possible within the hospital environment.
Intervention code [1] 301985 0
Treatment: Other
Comparator / control treatment

Control: Usual Care Intervention.
All participants in the Control group will continue to receive usual care interventions from a neonatal/paediatric physiotherapist. This will involve developmental input in the RNSH NICU and SCN (maximum contact 1 times per week), parent education and support, and ongoing physiotherapy follow-up at RNSH Community Health Centre after NICU discharge as deemed appropriate by the treating physiotherapist (maximum appointments 1x/month). Fraser chairs (supportive baby chairs) from the loan pool will also be provided to support development as deemed appropriate by the treating neonatal physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 306887 0
Alberta Motor Infant Scale (AIMS)
Timepoint [1] 306887 0
At Trial conclusion (16 weeks corrected age).
Secondary outcome [1] 350031 0
(i) Mental Health Self-report Measure: Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [1] 350031 0
At Trial conclusion (16 weeks corrected age)
Secondary outcome [2] 411608 0
General Movements Assessment
(12 weeks corrected gestational age)
Timepoint [2] 411608 0
The General Movements is being assessed at three timepoints: Preterm age, term age and 12 weeks corrected age.
The health outcome being assessed by this measure is Cerebral Palsy status.
Secondary outcome [3] 411609 0
Parents Perceptions Survey
Timepoint [3] 411609 0

16 weeks corrected gestational age
Secondary outcome [4] 411610 0
Bayley Scales of Infant Development version 4 (BSID4)
Timepoint [4] 411610 0
Assessed at 12 and 24 months corrected gestational age
Secondary outcome [5] 412611 0
Neurological Examination Outcomes - 12 months Corrected Age
Timepoint [5] 412611 0
12 months Corrected Age
Secondary outcome [6] 412612 0
Neurological Examination Outcomes - 24 months Corrected Age
Timepoint [6] 412612 0
24 months Corrected Age

Eligibility
Key inclusion criteria
The key inclusion criteria are (i) Infants deemed at risk of CP and (ii) parents likely to uptake parent-administered interventions for their infants and (iii) infants deemed likely to benefit from motor learning interventions. The criteria for eligibility include:
1. Any preterm or term Infant with other identifiable risk factors such as
(i) Grade 3 or 4 intra-ventricular haemorrhage (IVH), periventricular leukomalacia (PVL) and cystic PVL, periventricular infarction, lesions of the basal ganglia and thalamus, unilateral parenchymal injury, cortical malformation or other MRI identified brain injury eg ischaemic injury
(ii) seizures
(iii) significant post-natal infections infection such as meningitis, blood culture positive gram negative septicaemia or other congenitial TORCH infections (Toxoplasmosis, other [syphilis, varicella-zoster, parvovirus B19], Rubella, Cytomegalovirus (CMV), and Herpes infections).
(iv) chronic lung disease (CLD) who received post-natal dexamethasone
(v) Intra-uterine growth retardation (IUGR) = 3rd centile.
(vi) Abnormal General Movements assessment scoring cramped synchronous at term age in the “Writhing movements” period

2. Term infants with hypoxic ischaemic encephalopathy (HIE): Sarnat Stage 2 (moderate) or Sarnat Sage 3 (severe) or MRI identified brain injury

3. Preterm infants less than or equal to 27+6 weeks gestational age.
Minimum age
0 Weeks
Maximum age
16 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Parents unable to understand and speak English.
2. Infants with syndromes, cortical visual impairment (detected using the RICCI scale).
3. Retinopathy of Prematurity (ROP) Grade 3.
4. Significant auditory impairment.
5. Infants having undergone major surgery.

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)
Allocation concealment will ocur as follows:
1. member of staff (A) to screen infants for elegibility and consent obtained
2. baseline assessment performed
3. independent member of staff (B) contacted by staff member (A) for randomisation allocation
4. independent person (B) performed randomisation schedule with group allocation concealed in an opaque envolope
5. when envelope is opened by staff member (A) the participant is considered to have entered the trial dependent on randomisation outcome as either receiving usual care or experimental group interventions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Independent person to use a personal coputer to general a simple permuted block randomisation schedule with 15 participants each allocated to usual care or the experimental group.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Analysis Plan
Analysis will be conducted on an intention to treat basis using STATA/SPSS and reported according to the CONSORT statement. Appropriate descriptive statistics including frequencies, means/medians and 95% confidence intervals, will be used to describe the sample at baseline with data from the primary outcome measure (TIMP) and the secondary outcome measures (TIMP, GM, DASS-21 and HOME) summarised for each intervention group. Between group differences following intervention will be analysed using multiple regression to determine whether group allocation predicts outcome. Baseline data and age will entered as covariants into the regression analysis. The ‘centile’ routine in Stata (v9.2; Statacorp, TX, USA) may also be used to derive the 95% CIs for median between-group differences for data which is not normally distributed. This method does not make assumptions about the distribution of the data. A full statistical protocol will be developed before commencing data analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2019
Actual
9/09/2019
Date of last participant enrolment
Anticipated
Actual
27/10/2021
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11511 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 11521 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment postcode(s) [1] 23544 0
2077 - Hornsby

Funding & Sponsors
Funding source category [1] 300247 0
Commercial sector/Industry
Name [1] 300247 0
Ramsay Research and Teaching Fund
Country [1] 300247 0
Australia
Funding source category [2] 311788 0
Charities/Societies/Foundations
Name [2] 311788 0
The Research Foundation, the Cerebral Palsy Alliance.
Country [2] 311788 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Royal North Shore Hospital
Pacific Hwy
St Leonards
NSW
2065
Country
Australia
Secondary sponsor category [1] 299671 0
None
Name [1] 299671 0
Address [1] 299671 0
Country [1] 299671 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301070 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301070 0
Ethics committee country [1] 301070 0
Australia
Date submitted for ethics approval [1] 301070 0
24/11/2017
Approval date [1] 301070 0
25/06/2018
Ethics approval number [1] 301070 0
HREC reference: HREC/17/HAWKE/463

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

Contacts
Principal investigator
Name 85778 0
Dr Barbara Lucas
Address 85778 0
Physiotherapy Department, Buidling 30, Level2, Royal North Shore Hospital, St Leonards, NSW, 2065
Country 85778 0
Australia
Phone 85778 0
+61 2 9462 9747
Fax 85778 0
+61 2 9463 1068
Email 85778 0
barbara.lucas@health.nsw.gov.au
Contact person for public queries
Name 85779 0
Barbara Lucas
Address 85779 0
Physiotherapy Department, Buidling 30, Level 2, Royal North Shore Hospital, St Leonards, NSW, 2065
Country 85779 0
Australia
Phone 85779 0
+61 2 9462 9747
Fax 85779 0
+61 2 9463 1068
Email 85779 0
barbara.lucas@health.nsw.gov.au
Contact person for scientific queries
Name 85780 0
Barbara Lucas
Address 85780 0
Physiotherapy Department, Buidling 30, Level 2, Royal North Shore Hospital, St Leonards, NSW, 2065
Country 85780 0
Australia
Phone 85780 0
+61 2 9462 9747
Fax 85780 0
+61 2 9463 1068
Email 85780 0
barbara.lucas@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Primary and Secondary Outcome measures.
When will data be available (start and end dates)?
Data will published as a supplementary file with the paper. Data will be available for 5 years after publication.
Available to whom?
Anyone who has access to the journal which we publish in.
Available for what types of analyses?
Available of any types of analysis.
How or where can data be obtained?
As a supplementary file attached to the publication.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16547Ethical approval    375680-(Uploaded-14-04-2020-14-23-24)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.