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Lung Ultrasound for Infants' Swallowing Disorders

NCT04253951 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-06-22

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy
  • Pediatric Neurological Disorder
  • Developmental Disability

Interventions

DIAGNOSTIC_TEST

Lung Ultrasound (LUS)-monitored feeding trial

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. All pulmonary fields will be explored according to semeiotics and previous literature.

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • University of Pisa

    collaborator OTHER

  • Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

    collaborator OTHER_GOV

  • IRCCS Fondazione Stella Maris

    lead OTHER

Principal Investigators

  • Simona Fiori, MD, PhD · IRCCS Fondazione Stella Maris

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-09-15
Completion
2023-12-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04253951 on ClinicalTrials.gov