UnknownNot Applicable

Lung Ultrasound for Infants' Swallowing Disorders

Italy150 participantsStarted 2021-04-01

Plain-language summary

The aim is to test the effectiveness of lung ultrasound (LUS) in the dynamic assessment of aspiration related to abnormal swallowing in infants and young children with neurological impairment (cerebral palsy/developmental disabilities). Neither standardized measure is available, nor protocols for invasive fibre-optic endoscopic examination of swallowing (FEES) and x-Ray videofluoroscopic swallowing study (VFSS) to be used in such population. LUS offers several advantages: time saving for aspiration diagnosis; safeness (neither invasiveness nor radiation); repeatability with different meal consistencies or to monitor interventions efficacy; cost-effectiveness; savings of x-Ray exposition (compared to VFSS). All these advantages may lead infants to improve clinical behavioural and neurological outcomes and reduce stressful interactions with caregivers, and to reduce morbidities and hospitalization costs for respiratory and non-respiratory complications related to swallowing disorders.

Who can participate

Age range

3 Weeks – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

respiratory

Timeframe: long term (T4, at 6 months)

respiratory

Timeframe: short term (T3, at 3 months)

growth

Timeframe: long term (T4, at 6 months)

growth

Timeframe: short term (T3, at 3 months)

invasive diagnostic

Timeframe: long term (T4, at 6 months)

invasive diagnostic

Timeframe: short term (T3, at 3 months)

Trial details

NCT IDNCT04253951

SponsorIRCCS Fondazione Stella Maris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-15

Contact for this trial

Simona Fiori, MD, PhD

0039 050886310 s.fiori@fsm.unipi.it

View on ClinicalTrials.gov More Cerebral Palsy trials

Plain-language summary

Who can participate

Age range

3 Weeks – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

respiratory

Timeframe: long term (T4, at 6 months)

respiratory

Timeframe: short term (T3, at 3 months)

growth

Timeframe: long term (T4, at 6 months)

growth

Timeframe: short term (T3, at 3 months)

invasive diagnostic

Timeframe: long term (T4, at 6 months)

invasive diagnostic

Timeframe: short term (T3, at 3 months)