Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
150 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-04-01
Study Completion Date
2023-12-15
Brief Summary
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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.
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Detailed Description
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The dynamic use of LUS for monitoring feeding related aspiration can be effective in detecting meal-related pulmonary abnormalities in neurologically impaired infants and that LUS-management will improve medical/neurological/behavioural status, and reduce chronic pain/discomfort and stress for caregivers. LUS effectiveness is expected to reduce the need for x-Ray, invasive and more expensive techniques (VFSS and FEES). Results may be translated into clinical practice in the management of swallowing disorders in a very vulnerable population, by reducing invasiveness, possible x-Ray early exposition risks, costs, medical complications, and by assessing risk categories based on neuroimaging MRI markers, to rationalize prevention and intervention.
Preliminary data. LUS examinations have been performed on 6 infants with neurological impairment (mean age 15 ± 8 months; Gross Motor Function Classification System (GMFCS) range 2-5, median=4) and in 3 healthy infants (mean age 25 ± 3 months) before and right after a meal. A LUS score ranging from 0 to 18 was established, according to previous literature (0= normal pattern, 1= separated B-lines, 2= confluent B-lines or B-lines with pleural alterations, 3= consolidations; the score 0-3 was then calculated in all 6 thoracic scanning areas and summed up). In the 6 infants with neurological impairment, at paired sample t test, LUS score changed before and after meal (pre-meal 2.50±2.95 vs post-meal 5.17±3.25, p=0.01), with very large effect size (Cohen d=1.6). No change was detected in the control group. Changes in LUS score pre and post-meal correlated with GMFCS (p=0.03, r=0.64) and with adapted Eating and Drinking Ability Classification System (EDACS) scores (p=0.04, r=0.59), as more severe clinical pictures resulted in worse LUS scores. The LUS score pre- meal was worse in infants with neurological impairment compared to controls (2.50±2.95 vs 0.67±0.58, p=0.14). Results make LUS extremely promising as a tool to monitor pulmonary aeration changes in infants with neurological impairment. Feasibility of dorsal and ventral oromotor tract reconstruction has been tested in an infant with neurological impairment.
Specific Aim 1:
* To establish the feasibility and effectiveness of LUS-guided management in the detection of aspiration related to swallowing disorders in children with cerebral palsy and other developmental disabilities, determining advantages of LUS-guided management over standard care on medical (respiratory illness and growth rate) LUS findings themselves and behavioural/neurological outcomes
* To compare diagnostic accuracy of LUS versus X-ray VFSS and invasive FEES
Specific Aim 2:
\- To determine specific parameters to estimate aspiration entity by LUS (eg cut-off values for the diagnosis of clinically significant silent or overt aspiration, responsiveness of LUS monitoring to medical, postural or food consistencies adaptation) and their relationship with standardised clinical feeding evaluation and medical/behavioural/neurological measures in order to define risk groups for aspiration
Specific Aim 3:
* To evaluate other applications/potentialities of LUS in children with cerebral palsy and other developmental disabilities.
* To uncover the impact of brain abnormalities detected by brain MRI on LUS findings, for establishing risk categories for unsafe swallowing disorders on early imaging markers, and potential clinical recommendations for early management.
Experimental Design Aim 1:
Double-blinded randomized parallel-designed controlled trial (Consort checklist), 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). 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. Both the clinicians who will perform and score LUS, and the patients' family will be blinded to randomization. The child neurologist and the 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. All meals will be monitored by pulse-oximetry and video recording. A further 6-months LUS-monitored and clinical assessment (T4) will be delivered for collecting outcome measures in both treatment groups. At T0, T3 and T4 time points, infants will perform standardized medical/behavioural/neurological, chronic pain/discomfort assessments. At T0 and T4, a blood sample will be collected, to evaluate general and nutritional status, and a quantitative ultrasound (QUS) will be performed to evaluate bone density. A parent stress questionnaire (Parenting Stress Index (PSI)) will be delivered (T0, T3 and T4). Between T0 and T4, parents will be asked to fill a respiratory infection-diary for respiratory illness rate calculation. VFSS and FEES data will be collected, compared in frequency of execution between groups, and their results will be compared to LUS findings. Primary and secondary outcome measures will be collected at both T3 (short-term) and T4 (long-term).
Experimental Design Aim 2:
Aim 2 is based on the same design as Aim 1. We will explore the frequency, severity and distribution of basal and feeding related LUS parameters and their relationship with clinical (feeding assessment/medical/behavioural/neurological/chronic pain) measures, interventions (postural, thickening fluids or with drugs available for GERD), inter- and intra- group at any time point.
Other possible applications of LUS in the enrolled population will be collected (e.g. pneumonia detection and monitoring).
Experimental Design Aim 3:
Brain MRI is a clinical procedure in the diagnostic approach to children with neurological impairment. Brain abnormalities and corticobulbar tract integrity for lips, tongue, larynx motor and sensory control will be checked to uncover the neural circuits that may underlay swallowing problems leading to silent or overt aspiration and pulmonary risk estimated by LUS. Brain lesions topography and severity will be assessed by using a standardized MRI acquisition protocol according to the diagnostic procedure in use at Stella Maris Scientific Institute MRI Lab. Diffusion-weighted Imaging (DWI) will be used with the aim of revealing structural integrity and connectivity along white matter tracts involved in swallowing.
Expected outcomes:
the LUS-m group having better outcomes, at short- and long-term, including: having lower rate of pulmonary illness, better growth curve, reduction of execution rate of VFSS/FEES. Also, better results at blood sample and bone metabolism, lower pain indices, better scores at neurological/behavioural clinical measures, and less stressful interaction with caregivers.
Preliminary data. LUS examinations have been performed on 6 infants with neurological impairment (mean age 15 ± 8 months; Gross Motor Function Classification System (GMFCS) range 2-5, median=4) and in 3 healthy infants (mean age 25 ± 3 months) before and right after a meal. A LUS score ranging from 0 to 18 was established, according to previous literature (0= normal pattern, 1= separated B-lines, 2= confluent B-lines or B-lines with pleural alterations, 3= consolidations; the score 0-3 was then calculated in all 6 thoracic scanning areas and summed up). In the 6 infants with neurological impairment, at paired sample t test, LUS score changed before and after meal (pre-meal 2.50±2.95 vs post-meal 5.17±3.25, p=0.01), with very large effect size (Cohen d=1.6). No change was detected in the control group. Changes in LUS score pre and post-meal correlated with GMFCS (p=0.03, r=0.64) and with adapted Eating and Drinking Ability Classification System (EDACS) scores (p=0.04, r=0.59), as more severe clinical pictures resulted in worse LUS scores. The LUS score pre- meal was worse in infants with neurological impairment compared to controls (2.50±2.95 vs 0.67±0.58, p=0.14). Results make LUS extremely promising as a tool to monitor pulmonary aeration changes in infants with neurological impairment. Feasibility of dorsal and ventral oromotor tract reconstruction has been tested in an infant with neurological impairment.
Specific Aim 1:
* To establish the feasibility and effectiveness of LUS-guided management in the detection of aspiration related to swallowing disorders in children with cerebral palsy and other developmental disabilities, determining advantages of LUS-guided management over standard care on medical (respiratory illness and growth rate) LUS findings themselves and behavioural/neurological outcomes
* To compare diagnostic accuracy of LUS versus X-ray VFSS and invasive FEES
Specific Aim 2:
\- To determine specific parameters to estimate aspiration entity by LUS (eg cut-off values for the diagnosis of clinically significant silent or overt aspiration, responsiveness of LUS monitoring to medical, postural or food consistencies adaptation) and their relationship with standardised clinical feeding evaluation and medical/behavioural/neurological measures in order to define risk groups for aspiration
Specific Aim 3:
* To evaluate other applications/potentialities of LUS in children with cerebral palsy and other developmental disabilities.
* To uncover the impact of brain abnormalities detected by brain MRI on LUS findings, for establishing risk categories for unsafe swallowing disorders on early imaging markers, and potential clinical recommendations for early management.
Experimental Design Aim 1:
Double-blinded randomized parallel-designed controlled trial (Consort checklist), 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). 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. Both the clinicians who will perform and score LUS, and the patients' family will be blinded to randomization. The child neurologist and the 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. All meals will be monitored by pulse-oximetry and video recording. A further 6-months LUS-monitored and clinical assessment (T4) will be delivered for collecting outcome measures in both treatment groups. At T0, T3 and T4 time points, infants will perform standardized medical/behavioural/neurological, chronic pain/discomfort assessments. At T0 and T4, a blood sample will be collected, to evaluate general and nutritional status, and a quantitative ultrasound (QUS) will be performed to evaluate bone density. A parent stress questionnaire (Parenting Stress Index (PSI)) will be delivered (T0, T3 and T4). Between T0 and T4, parents will be asked to fill a respiratory infection-diary for respiratory illness rate calculation. VFSS and FEES data will be collected, compared in frequency of execution between groups, and their results will be compared to LUS findings. Primary and secondary outcome measures will be collected at both T3 (short-term) and T4 (long-term).
Experimental Design Aim 2:
Aim 2 is based on the same design as Aim 1. We will explore the frequency, severity and distribution of basal and feeding related LUS parameters and their relationship with clinical (feeding assessment/medical/behavioural/neurological/chronic pain) measures, interventions (postural, thickening fluids or with drugs available for GERD), inter- and intra- group at any time point.
Other possible applications of LUS in the enrolled population will be collected (e.g. pneumonia detection and monitoring).
Experimental Design Aim 3:
Brain MRI is a clinical procedure in the diagnostic approach to children with neurological impairment. Brain abnormalities and corticobulbar tract integrity for lips, tongue, larynx motor and sensory control will be checked to uncover the neural circuits that may underlay swallowing problems leading to silent or overt aspiration and pulmonary risk estimated by LUS. Brain lesions topography and severity will be assessed by using a standardized MRI acquisition protocol according to the diagnostic procedure in use at Stella Maris Scientific Institute MRI Lab. Diffusion-weighted Imaging (DWI) will be used with the aim of revealing structural integrity and connectivity along white matter tracts involved in swallowing.
Expected outcomes:
the LUS-m group having better outcomes, at short- and long-term, including: having lower rate of pulmonary illness, better growth curve, reduction of execution rate of VFSS/FEES. Also, better results at blood sample and bone metabolism, lower pain indices, better scores at neurological/behavioural clinical measures, and less stressful interaction with caregivers.
Conditions
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Cerebral Palsy
Pediatric Neurological Disorder
Developmental Disability
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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).
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
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.
Study Groups
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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.
Group Type
EXPERIMENTAL
Lung Ultrasound (LUS)-monitored feeding trial
Intervention Type
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.
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.
Group Type
SHAM_COMPARATOR
Lung Ultrasound (LUS)-monitored feeding trial
Intervention Type
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.
Interventions
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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.
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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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.
* 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
* drugs for muscle tone abnormalities or GERD introduced or modified less than 3 weeks before potential enrollment
Minimum Eligible Age
3 Weeks
Maximum Eligible Age
6 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ministry of Health, Italy
OTHER_GOV
Sponsor Role
collaborator
University of Pisa
OTHER
Sponsor Role
collaborator
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
OTHER_GOV
Sponsor Role
collaborator
IRCCS Fondazione Stella Maris
OTHER
Sponsor Role
lead
Responsible Party
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Simona Fiori
Principal Investigator, MD, PhD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Simona Fiori, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Fondazione Stella Maris
Locations
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IRCCS Fondazione Stella Maris
Tirrenia, Tuscany, Italy
Site Status
RECRUITING
IRCCS Fondazione Stella Maris
Pisa, , Italy
Site Status
NOT_YET_RECRUITING
Countries
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Italy
Central Contacts
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Facility Contacts
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References
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Srivastava R, Jackson WD, Barnhart DC. Dysphagia and gastroesophageal reflux disease: dilemmas in diagnosis and management in children with neurological impairment. Pediatr Ann. 2010 Apr;39(4):225-31. doi: 10.3928/00904481-20100318-07. No abstract available.
Reference Type
RESULT
Fitzgerald DA, Follett J, Van Asperen PP. Assessing and managing lung disease and sleep disordered breathing in children with cerebral palsy. Paediatr Respir Rev. 2009 Mar;10(1):18-24. doi: 10.1016/j.prrv.2008.10.003. Epub 2009 Jan 23.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Raimondi F, Migliaro F, Sodano A, Umbaldo A, Romano A, Vallone G, Capasso L. Can neonatal lung ultrasound monitor fluid clearance and predict the need of respiratory support? Crit Care. 2012 Nov 14;16(6):R220. doi: 10.1186/cc11865.
Reference Type
RESULT
Raimondi F, Migliaro F, Sodano A, Ferrara T, Lama S, Vallone G, Capasso L. Use of neonatal chest ultrasound to predict noninvasive ventilation failure. Pediatrics. 2014 Oct;134(4):e1089-94. doi: 10.1542/peds.2013-3924. Epub 2014 Sep 1.
Reference Type
RESULT
Gargani L, Volpicelli G. How I do it: lung ultrasound. Cardiovasc Ultrasound. 2014 Jul 4;12:25. doi: 10.1186/1476-7120-12-25.
Reference Type
RESULT
Balk DS, Lee C, Schafer J, Welwarth J, Hardin J, Novack V, Yarza S, Hoffmann B. Lung ultrasound compared to chest X-ray for diagnosis of pediatric pneumonia: A meta-analysis. Pediatr Pulmonol. 2018 Aug;53(8):1130-1139. doi: 10.1002/ppul.24020. Epub 2018 Apr 26.
Reference Type
RESULT
Brenner D, Elliston C, Hall E, Berdon W. Estimated risks of radiation-induced fatal cancer from pediatric CT. AJR Am J Roentgenol. 2001 Feb;176(2):289-96. doi: 10.2214/ajr.176.2.1760289.
Reference Type
RESULT
Goh YR, Choi JY, Kim SA, Park J, Park ES. Comparisons of severity classification systems for oropharyngeal dysfunction in children with cerebral palsy: Relations with other functional profiles. Res Dev Disabil. 2018 Jan;72:248-256. doi: 10.1016/j.ridd.2017.12.002. Epub 2017 Dec 7.
Reference Type
RESULT
Pandis N, Chung B, Scherer RW, Elbourne D, Altman DG. CONSORT 2010 statement: extension checklist for reporting within person randomised trials. BMJ. 2017 Jun 30;357:j2835. doi: 10.1136/bmj.j2835.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
O'Rourke D. The measurement of pain in infants, children, and adolescents: from policy to practice. Phys Ther. 2004 Jun;84(6):560-70. No abstract available.
Reference Type
RESULT
Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. No abstract available.
Reference Type
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.
Reference Type
DERIVED
Other Identifiers
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LUNCH-2019
Identifier Type: -
Identifier Source: org_study_id
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Management of Drooling in Children With Cerebral Palsy in France
NCT02797106
COMPLETED
Utility of Bedside Ultrasound in the Prediction of Difficult Airway
NCT00799357
COMPLETED
Swallowing and Oral Sensory Complaints in Preterm Children
NCT06881381
COMPLETED
Nasalance Scores for Normal-speaking French Children
NCT04934306
COMPLETED
Neonatal Neurological Examination to Detect Infants at Risk
NCT05772416
UNKNOWN
Early Identification of Infants at Risk of Cerebral Palsy
NCT03211533
COMPLETED
Effect of Different Viscous Foods and Liquids on Swallowing Sounds
NCT03024333
COMPLETED
Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure
NCT06406725
RECRUITING
Ultrasound Imaging of Subarachnoidal Space in Newborn Infants
NCT04004130
UNKNOWN
NA
3D-CT-Based Prediction of Difficult Laryngoscopy in Infants With Pierre Robin Sequence
NCT07257276
ACTIVE_NOT_RECRUITING
Skeletal Muscle Ultrasonography in Detection of Malnutrition
NCT06382766
NOT_YET_RECRUITING
Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy
NCT03230032
COMPLETED
NA
Feeding and Swallowing Problems in Infants With Laryngomalacia
NCT05337475
COMPLETED
Clinical and Laboratory Predictors of Respiratory Morbidities in CP Children
NCT05053776
UNKNOWN