None listed
Conditions
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
Interventions
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, motiva
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.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 12 Months
Healthy volunteers
No
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.
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
Outcome results
None listed