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Lung Ultrasound for Infants' Swallowing Disorders (LUNCH)

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ClinicalTrials.gov Identifier: NCT04253951
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Ministry of Health, Italy
University of Pisa
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Information provided by (Responsible Party):
Simona Fiori, IRCCS Fondazione Stella Maris

Brief 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Pediatric Neurological Disorder Developmental Disability Diagnostic Test: Lung Ultrasound (LUS)-monitored feeding trial Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded randomized parallel-designed controlled trial (Consort checklist, 21), with block randomization (blocks of size 4), in one of 2 groups: 1) LUS-monitored management (LUS-m); 2) Standard care management (SC-m). Both groups will undergo an experimental 6-months follow-up. 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).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Both the clinicians who will perform and score LUS, and the patients' family will be blinded to randomization. The care providers (child neurologist and speech and language pathologist (SLP) will be informed of the result of LUS only in the LUS-m group and will include that result to impact on feeding care (postural, thickening fluids or with drugs available for GERD). LUS results in the SC-m group will be available only at the time of data analyses.
Primary Purpose: Diagnostic
Official Title: Lung Ultrasound for Early Detection of Silent and Apparent aspiratioN in Infants and Young CHildren With Cerebral Palsy and Other Developmental Disabilities: a New Fast, Safe, Cost-effective Infant-friendly Imaging Tool to Easily Monitor Feeding , Improve Outcomes and Reduce Morbidities (LUNCH)
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : September 15, 2022
Estimated Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LUS-monitored management (LUS-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.
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.

Sham Comparator: Standard care management (SC-m)
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.
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.




Primary Outcome Measures :
  1. respiratory [ Time Frame: long term (T4, at 6 months) ]
    respiratory illness rate (including pneumonia, wheezing, chronic cough, and apnoea rate)

  2. respiratory [ Time Frame: short term (T3, at 3 months) ]
    respiratory illness rate (including pneumonia, wheezing, chronic cough, and apnoea rate)

  3. growth [ Time Frame: long term (T4, at 6 months) ]
    growth rate

  4. growth [ Time Frame: short term (T3, at 3 months) ]
    growth rate

  5. invasive diagnostic [ Time Frame: long term (T4, at 6 months) ]
    VFSS/FEES execution rates

  6. invasive diagnostic [ Time Frame: short term (T3, at 3 months) ]
    VFSS/FEES execution rates


Secondary Outcome Measures :
  1. change from baseline laboratory exam at 6 months [ Time Frame: baseline-long term (T4, at 6 months) ]
    blood cells count

  2. change from baseline laboratory exam at 6 months [ Time Frame: baseline-long term (T4, at 6 months) ]
    reticulocytes count

  3. change from baseline laboratory exam at 6 months [ Time Frame: baseline- long term (T4, at 6 months) ]
    total serum protein

  4. change from baseline laboratory exam at 6 months [ Time Frame: baseline- long term (T4, at 6 months) ]
    ferritin

  5. chronic pain assessment [ Time Frame: short term (T3, at 3 months) ]
    parents-report measure (Non-communicating Children's Pain Checklist, NCCPC), with scores ranging from 0 to 90, with higher scores corresponding to worse outcome

  6. chronic pain assessment [ Time Frame: long term (T4, at 6 months) ]
    parents-report measure (Non-communicating Children's Pain Checklist, NCCPC), with scores ranging from 0 to 90, with higher scores corresponding to worse outcome

  7. parents' stress [ Time Frame: long term (T4, at 6 months) ]
    Parenting Stress Index questionnaire (PSI), with scores ranging from 0 to 120 including 4 domains, with higher scores corresponding to worse outcome


Other Outcome Measures:
  1. neurological outcome [ Time Frame: short term (T3, at 3 months) and long term (T4, at 6 months) ]
    Hammersmith Infant Neurological Examination (HINE), with scores ranging from 0 to 78, with higher scores corresponding to better outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253951


Contacts
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Contact: Simona Fiori, MD, PhD 0039 050886310 s.fiori@fsm.unipi.it
Contact: Elena Moretti, SLP 0039 050886310 e.moretti@fsm.unipi.it

Locations
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Italy
IRCCS Fondazione Stella Maris
Pisa, Italy, 56128
Contact: Simona Fiori, MD, PhD    0039 050886310    s.fiori@fsm.unipi.it   
Contact: Giovanni Cioni, MD    0039 050886229    dirscient@fsm.unipi.it   
Sponsors and Collaborators
IRCCS Fondazione Stella Maris
Ministry of Health, Italy
University of Pisa
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Investigators
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Principal Investigator: Simona Fiori, MD, PhD IRCCS Fondazione Stella Maris
Publications of Results:

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Responsible Party: Simona Fiori, Principal Investigator, MD, PhD, IRCCS Fondazione Stella Maris
ClinicalTrials.gov Identifier: NCT04253951    
Other Study ID Numbers: LUNCH-2019
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simona Fiori, IRCCS Fondazione Stella Maris:
abnormal swallowing
infants and young children with neurological impairment
lung ultrasound
apparent aspiration
silent aspiration
Additional relevant MeSH terms:
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Cerebral Palsy
Developmental Disabilities
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders