Lung Ultrasound for Infants' Swallowing Disorders (LUNCH)
Cerebral Palsy, Pediatric Neurological Disorder, Developmental Disability
About this trial
This is an interventional diagnostic trial for Cerebral Palsy focused on measuring abnormal swallowing, infants and young children with neurological impairment, lung ultrasound, apparent aspiration, silent aspiration
Eligibility Criteria
Inclusion Criteria:
- cerebral palsy or abnormal muscular tone at any age between 0-3 years of life due disorders other than cerebral palsy;
- motor developmental delay assessed by a quantitative scale for infants and young children development (<5 sd according to age)
- in absence of the previous clinical indices, if there is the clinical suspicion of GERD or dysphagia based on clinical symptoms
- a brain MRI acquisition done before or programmed prior the end of the study period as part of their diagnostic procedure.
Exclusion Criteria:
- epileptic spasm
- drugs for muscle tone abnormalities or GERD introduced or modified less than 3 weeks before potential enrollment
Sites / Locations
- IRCCS Fondazione Stella MarisRecruiting
- IRCCS Fondazione Stella Maris
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
LUS-monitored management (LUS-m)
Standard care management (SC-m)
In the first 3 months, participants will be evaluated a minimum of 1 time per month, in-hospital, for a total of 3 evaluations (T1, T2 and T3), plus baseline (T0). At any time point, they will undergo at least one LUS-monitored (before and after) feeding trial (different consistencies might be tested in separate repeated trials according to clinical evaluation). A further LUS evaluation will be performed at a distance of 3 hours, before the next meal to check for resolution of after-meal abnormalities.
Sham protocol with LUS performed at the same timepoints. LUS results in the SC-m group will be available only at the time of data analyses for comparison by investigators. They will not be used for clinical decisions.