Intensive Early Adaptive Therapy (I-EAT) to Improve Feeding and Swallowing: A Clinical Trial for Infants at Risk of Cerebral Palsy.

INTERVENTION: 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. CONDITION: cerebral palsy dysphagia PRIMARY OUTCOME: 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. SECONDARY OUTCOME: Family stress assessed using Feeding Swallowing Impact Survey Feeding and swallowing skills (composite outcome) assessed by clinical feeding evaluation using Eating Drinking Ability Classification Scale (EDACS). 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. 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, Health assessed by height and weight compared against CDC growth charts, Health assessed by incidence of chest infection, as reported in participants' medical records (where available) or parent‐report of diagnosis or prescription of antibiotics Instrumental assessment will be conducted using Fibreoptic Endoscopic Evaluation of Swallowing with Penetration Aspiration Scale and Yale Pharyngeal Residue Severity Rating Scale. 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. 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). 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.