Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000305224
Ethics application status
Approved
Date submitted
18/10/2017
Date registered
1/03/2018
Date last updated
1/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Intensive Early Adaptive Therapy (I-EAT) to Improve Feeding and Swallowing: A Clinical Trial for Infants at Risk of Cerebral Palsy.
Scientific title
An assessor blinded, parallel group randomized 12-week pilot study comparing effectiveness of the Intensive Early Active Treatment (I-EAT) program to usual care on feeding and swallowing in infants at risk of cerebral palsy
Secondary ID [1] 293166 0
None
Universal Trial Number (UTN)
U1111-1203-9517
Trial acronym
I-EAT
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 305146 0
dysphagia 305147 0
Condition category
Condition code
Neurological 304466 304466 0 0
Other neurological disorders
Oral and Gastrointestinal 304469 304469 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a single blind randomised controlled trial with two groups.
Group 1 will receive 12 weeks of the Intensive-Early Adaptive Treatment (I-EAT) program, a graded eating, drinking and/or swallowing intervention approach based on motor learning principles. A speech pathologist experienced in feeding difficulties will provide intensive intervention for this group at the participants' homes.

Interventions will be grounded in motor learning principles, be intensive, provided early, motivating and embedded into functional tasks. Interventions will be individualised based on the participants' skills, progress and their family. Parents will be requested to practice eating, drinking and/or swallowing regularly during the program and compete a log of practice.
Intervention code [1] 299415 0
Treatment: Other
Comparator / control treatment
Group 2 will receive 12-weeks of standard care intervention provided by community or out-patient speech pathology services, as is current standard practice. For those participants randomised to standard care, study investigators will provide parents a selection of appropriate and local service providers and refer participants (or facilitate medical referral, if required) to the service of the parents’ choosing. Parents will be required to keep a log of intervention and practice.
Control group
Active

Outcomes
Primary outcome [1] 303706 0
To determine if parents of infants at risk of or have been diagnosed with CP and have feeding difficulties deem the I-EAT program and standard care to be feasible and acceptable interventions. A Feeding Intervention Preference Questionnaire will be completed by parents.
Timepoint [1] 303706 0
Baseline and at completion of 12-weeks of intervention.
Secondary outcome [1] 339915 0
Percentage of recommended calories consumed orally versus by tube. Determined from 3-day infant’s feeding diary of all food and fluids consumed in three-days prior to assessment session as recorded by parents, compared to recommendations made by dietitian or paediatrician (where available) or NHMRC Eat For Health: Infant Feeding Guidelines (2012).
Timepoint [1] 339915 0
Baseline and at completion of 12-weeks of intervention.
Secondary outcome [2] 339916 0
Oral feeding efficiency, assessed by volume consumed in first and last 5 minutes and 30 minutes and time to complete meal. Volume consumed in first and last 5 minutes and total volume consumed in 30 minutes will be recorded by subtracting the weight of the food or fluid taken with digital food scales (grams) with the starting weight of the food or fluid. Length of mealtime (minutes) will be taken with a digital timer from the first food or fluid offered to the last food or fluid offered.
Timepoint [2] 339916 0
At baseline and at completion of 12-weeks of intervention.
Secondary outcome [3] 339917 0
Feeding and swallowing skills assessed by clinical feeding evaluation using Dysphagia Disorders Survey for Infants Dysphagia Management Staging Scale for Infants using cervical auscultation to aid decision making,
Timepoint [3] 339917 0
At baseline and at completion of 12-weeks of intervention.
Secondary outcome [4] 339918 0
Health assessed by height and weight compared against CDC growth charts,
Timepoint [4] 339918 0
At baseline and at completion of 12-weeks of intervention.
Secondary outcome [5] 342392 0
Family stress assessed using Feeding Swallowing Impact Survey
Timepoint [5] 342392 0
At baseline and at completion of 12-weeks of intervention.
Secondary outcome [6] 342951 0
Health assessed by incidence of chest infection, as reported in participants' medical records (where available) or parent-report of diagnosis or prescription of antibiotics
Timepoint [6] 342951 0
Baseline (for all previous incidences) and at completion of 12-weeks intervention.
Secondary outcome [7] 343627 0
Feeding and swallowing skills (composite outcome) assessed by clinical feeding evaluation using Eating Drinking Ability Classification Scale (EDACS).
Timepoint [7] 343627 0
Baseline and at completion of 12-weeks intervention
Secondary outcome [8] 343628 0
Feeding and swallowing skills (composite outcome) assessed by International Dysphagia Diet Standardisation Initiative (IDDSI) level for food and fluids noting number of compensatory strategies required for safe oral feeding based on recommended by the speech pathologist conducting assessment.
Timepoint [8] 343628 0
Baseline and at completion of 12-weeks intervention
Secondary outcome [9] 343629 0
Instrumental assessment will be conducted using Fibreoptic Endoscopic Evaluation of Swallowing with Penetration Aspiration Scale and Yale Pharyngeal Residue Severity Rating Scale.
Timepoint [9] 343629 0
Baseline and at completion of 12-weeks intervention

Eligibility
Key inclusion criteria
• Infants 37 weeks PMA to 12 months corrected age, AND
• Diagnosed with or identified as at risk of cerebral palsy, as determined by evidence of injury indicative of or likely to result in CP as determined by positive brain imaging, diagnosis of hypoxic–ischemic encephalopathy or condition with high association of CP, absent fidgety movements on the General Movements Assessment (from 3 months of age), or report indicating risk or diagnosis of CP from neurologist or paediatrician, AND
• Oropharyngeal dysphagia as diagnosed by speech pathologist, AND
• Receiving at least 20% of recommended nutrition orally, AND
• Parent/carer report that they are willing and able to carry out intervention dose.
Minimum age
0 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Infants whose feeding impairment is primarily cardiac, respiratory or gastrointestinal related
• Infants with craniofacial anomalies that may impact feeding ability
• Infants at risk of aspiration that is not able to be resolved through compensatory strategies such as positioning, food or fluid consistency modification pacing or external supports i.e. infants who are recommended nil by mouth
• Infants residing in remote areas not accessible to the research team

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)
Simple random allocation will be conducted at a separate location by an independent randomisation officer using computer based sequences. The independent randomisation officer will provide concealed opaque envelopes containing group allocation to the principal investigators who will notify participants’ parents of group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple random allocation will be conducted at a separate location by an independent randomisation officer using computer based sequences.
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
Analysis will be conducted on an intention to treat basis. The sample baseline characteristics will be described using descriptive statistics. Normality assumptions will be checked using numerical and graphical means. Assuming normality, between group differences will be investigated using independent t-tests and between group differences using paired t-tests. Non-parametric alternatives will be used if normality assumptions are not met.
Assuming normality and model assumptions, the outcomes following intervention will be compared using multiple regression analysis to assess between group differences and determine whether group allocation is associated with outcomes. If the data is not normal, investigations will be undertaken for clinical significance of outliers and/or transformations of data if necessary. Non-parametric alternatives will also be considered.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/03/2018
Actual
Date of last participant enrolment
Anticipated
1/10/2019
Actual
Date of last data collection
Anticipated
20/12/2019
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9204 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 17858 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 297794 0
Charities/Societies/Foundations
Name [1] 297794 0
Cerebral Palsy Alliance Research Institute
Country [1] 297794 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The Children's Hospital at Westmead Clinical School
Discipline of Child and Adolescent Health
Locked Bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 296832 0
None
Name [1] 296832 0
None
Address [1] 296832 0
None
Country [1] 296832 0
Other collaborator category [1] 279773 0
Charities/Societies/Foundations
Name [1] 279773 0
Cerebral Palsy Alliance Research Institute
Address [1] 279773 0
PO Box 6427,
Frenchs Forest,
NSW 2086
Country [1] 279773 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298852 0
Sydney Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 298852 0
Ethics committee country [1] 298852 0
Australia
Date submitted for ethics approval [1] 298852 0
23/10/2017
Approval date [1] 298852 0
24/01/2018
Ethics approval number [1] 298852 0
HREC/17/SCHN/432

Summary
Brief summary
The primary purpose of this pilot RCT is to investigate whether parents of infants at risk of CP with feeding difficulties deem standard care and a new feeding therapy for infants, called “I-EAT” feasible and acceptable interventions. The secondary outcomes are to:
• document the range of practices used in the standard care arm.
• estimate:
o volume of oral consumption,
o oral feeding efficiency,
o oral feeding and swallowing skills,
o measures of health, and
o family stress, in infants who are at risk of or have been diagnosed with cerebral palsy and have feeding difficulties, under both the I-EAT program and standard care.
• perform exploratory comparisons of feeding and other outcomes between the two study arms with a view to design of a confirmatory study.

Hypotheses:
• We hypothesise that parents will find both the I-EAT program and standard care feasible and acceptable interventions
• We hypothesise that by the end of the intervention infants receiving the I-EAT program will:
o consume at least 20% more of their recommended nutrition orally,
o consume at least 20% more of their recommended meal during 30 minute mealtime
o require a reduction of at least one compensatory strategies required, and
o be no worse on growth trajectory, incidence of aspiration pneumonia or feeding related hospitalisations.
• We hypothesise that parents receiving the I-EAT program will report an improvement of at least 20% on the Feeding Swallowing Impact Survey
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78446 0
Ms Amanda Spirit-Jones
Address 78446 0
Cerebral Palsy Alliance
Building G
Western Sydney University
Second Ave
Kingswood
NSW 2747
Country 78446 0
Australia
Phone 78446 0
+61416275655
Fax 78446 0
Email 78446 0
aspiritjones@cerebralpalsy.org.au
Contact person for public queries
Name 78447 0
Ms Amanda Spirit-Jones
Address 78447 0
Cerebral Palsy Alliance
Building G
Western Sydney University
Second Ave
Kingswood
NSW 2747
Country 78447 0
Australia
Phone 78447 0
+61416275655
Fax 78447 0
Email 78447 0
aspiritjones@cerebralpalsy.org.au
Contact person for scientific queries
Name 78448 0
Ms Amanda Spirit-Jones
Address 78448 0
Cerebral Palsy Alliance
Building G
Western Sydney University
Second Ave
Kingswood
NSW 2747
Country 78448 0
Australia
Phone 78448 0
+61416275655
Fax 78448 0
Email 78448 0
aspiritjones@cerebralpalsy.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBaby Intensive Early Active Treatment (babiEAT): A Pilot Randomised Controlled Trial of Feeding Therapy for Infants with Cerebral Palsy and Oropharyngeal Dysphagia.2023https://dx.doi.org/10.3390/jcm12072677
N.B. These documents automatically identified may not have been verified by the study sponsor.