Lung Ultrasound for Infants' Swallowing Disorders

NCT04253951 | Unknown DMC

• 1 other identifier: LUNCH-2019
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy; Pediatric Neurological Disorder; Developmental Disability

Keywords

abnormal swallowing; infants and young children with neurological impairment; lung ultrasound; apparent aspiration; silent aspiration

Outcome Measures

Primary Outcomes (6)

• respiratory

  respiratory illness rate (including pneumonia, wheezing, chronic cough, and apnoea rate)

  long term (T4, at 6 months)

• respiratory

  respiratory illness rate (including pneumonia, wheezing, chronic cough, and apnoea rate)

  short term (T3, at 3 months)

• growth

  growth rate

  long term (T4, at 6 months)

• growth

  growth rate

  short term (T3, at 3 months)

• invasive diagnostic

  VFSS/FEES execution rates

  long term (T4, at 6 months)

• invasive diagnostic

  VFSS/FEES execution rates

  short term (T3, at 3 months)

Secondary Outcomes (7)

• change from baseline laboratory exam at 6 months

  baseline-long term (T4, at 6 months)

• change from baseline laboratory exam at 6 months

  baseline-long term (T4, at 6 months)

• change from baseline laboratory exam at 6 months

  baseline- long term (T4, at 6 months)

• change from baseline laboratory exam at 6 months

  baseline- long term (T4, at 6 months)

• chronic pain assessment

  short term (T3, at 3 months)

Other Outcomes (1)

• neurological outcome

  short term (T3, at 3 months) and long term (T4, at 6 months)

Study Arms (2)

LUS-monitored management (LUS-m)

EXPERIMENTAL

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

Standard care management (SC-m)

SHAM COMPARATOR

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

Interventions

Lung Ultrasound (LUS)-monitored feeding trial DIAGNOSTIC_TEST

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.

LUS-monitored management (LUS-m); Standard care management (SC-m)

Eligibility Criteria

• Age: 3 Weeks - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• epileptic spasm
• drugs for muscle tone abnormalities or GERD introduced or modified less than 3 weeks before potential enrollment

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• Ministry of Health, Italy: collaborator
• University of Pisa: collaborator
• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: collaborator

Study Sites (2)

IRCCS Fondazione Stella Maris

Tirrenia, Tuscany, 56128, Italy

RECRUITING

IRCCS Fondazione Stella Maris

Pisa, 56128, Italy

NOT YET RECRUITING

Related Publications (24)

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  PMID: 19203740 RESULT

• Arvedson J, Rogers B, Buck G, Smart P, Msall M. Silent aspiration prominent in children with dysphagia. Int J Pediatr Otorhinolaryngol. 1994 Jan;28(2-3):173-81. doi: 10.1016/0165-5876(94)90009-4.

  PMID: 8157416 RESULT

• Blackmore AM, Bear N, Blair E, Gibson N, Jalla C, Langdon K, Moshovis L, Steer K, Wilson AC. Factors Associated with Respiratory Illness in Children and Young Adults with Cerebral Palsy. J Pediatr. 2016 Jan;168:151-157.e1. doi: 10.1016/j.jpeds.2015.09.064. Epub 2015 Oct 29.

  PMID: 26520916 RESULT

• Pillai Riddell RR, Stevens BJ, McKeever P, Gibbins S, Asztalos L, Katz J, Ahola S, Din L. Chronic pain in hospitalized infants: health professionals' perspectives. J Pain. 2009 Dec;10(12):1217-25. doi: 10.1016/j.jpain.2009.04.013. Epub 2009 Jun 21.

  PMID: 19541547 RESULT

• Benfer KA, Weir KA, Boyd RN. Clinimetrics of measures of oropharyngeal dysphagia for preschool children with cerebral palsy and neurodevelopmental disabilities: a systematic review. Dev Med Child Neurol. 2012 Sep;54(9):784-95. doi: 10.1111/j.1469-8749.2012.04302.x. Epub 2012 May 14.

  PMID: 22582745 RESULT

• van den Engel-Hoek L, Erasmus CE, van Hulst KC, Arvedson JC, de Groot IJ, de Swart BJ. Children with central and peripheral neurologic disorders have distinguishable patterns of dysphagia on videofluoroscopic swallow study. J Child Neurol. 2014 May;29(5):646-53. doi: 10.1177/0883073813501871. Epub 2013 Sep 9.

  PMID: 24022110 RESULT

• Calvo I, Conway A, Henriques F, Walshe M. Diagnostic accuracy of the clinical feeding evaluation in detecting aspiration in children: a systematic review. Dev Med Child Neurol. 2016 Jun;58(6):541-53. doi: 10.1111/dmcn.13058. Epub 2016 Feb 9.

  PMID: 26862075 RESULT

• Cichero J, Nicholson T, Dodrill P. Liquid barium is not representative of infant formula: characterisation of rheological and material properties. Dysphagia. 2011 Sep;26(3):264-71. doi: 10.1007/s00455-010-9303-3. Epub 2010 Sep 10.

  PMID: 20830598 RESULT

• Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689.

  PMID: 28715518 RESULT

• Uhm KE, Yi SH, Chang HJ, Cheon HJ, Kwon JY. Videofluoroscopic swallowing study findings in full-term and preterm infants with Dysphagia. Ann Rehabil Med. 2013 Apr;37(2):175-82. doi: 10.5535/arm.2013.37.2.175. Epub 2013 Apr 30.

  PMID: 23705111 RESULT

• Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

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  PMID: 24993976 RESULT

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  PMID: 29696826 RESULT

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  PMID: 29223113 RESULT

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• Liegeois FJ, Butler J, Morgan AT, Clayden JD, Clark CA. Anatomy and lateralization of the human corticobulbar tracts: an fMRI-guided tractography study. Brain Struct Funct. 2016 Jul;221(6):3337-45. doi: 10.1007/s00429-015-1104-x. Epub 2015 Sep 28.

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• Erasmus CE, van Hulst K, Rotteveel JJ, Willemsen MA, Jongerius PH. Clinical practice: swallowing problems in cerebral palsy. Eur J Pediatr. 2012 Mar;171(3):409-14. doi: 10.1007/s00431-011-1570-y. Epub 2011 Sep 20.

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  PMID: 25501898 RESULT

• Fiori S, Scaramuzzo RT, Moretti E, Amador C, Controzzi T, Martinelli A, Filippi L, Guzzetta A, Gargagni L. LUNCH-Lung Ultrasound for early detection of silent and apparent aspiratioN in infants and young CHildren with cerebral palsy and other developmental disabilities: study protocol of a randomized controlled trial. BMC Pediatr. 2022 Jun 23;22(1):360. doi: 10.1186/s12887-022-03413-z.

  PMID: 35739502 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Developmental Disabilities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Simona Fiori, MD, PhD

  IRCCS Fondazione Stella Maris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Fiori, MD, PhD

CONTACT

0039 050886310; s.fiori@fsm.unipi.it

Elena Moretti, SLP

CONTACT

0039 050886310; e.moretti@fsm.unipi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Model Details: 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).

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: April 1, 2021
• Primary Completion: September 15, 2023
• Study Completion: December 15, 2023
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)