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

S Fiori, R T Scaramuzzo, E Moretti, C Amador, T Controzzi, A Martinelli, L Filippi, A Guzzetta, L Gargagni, S Fiori, R T Scaramuzzo, E Moretti, C Amador, T Controzzi, A Martinelli, L Filippi, A Guzzetta, L Gargagni

Abstract

Background: Children with neurological impairment may have dysphagia and/or gastro-esophageal reflux disease (GERD), which predispose to complications affecting the airways, increasing risk for aspiration-induced acute and chronic lung disease, or secondarily malnutrition, further neurodevelopmental disturbances, stressful interactions with their caregivers and chronic pain. Only multidisciplinary clinical feeding evaluation and empirical trials are applied to provide support to the management of feeding difficulties related to dysphagia or GERD, but no standardized feeding or behavioral measure exists at any age to assess aspiration risk and support the indication to perform a videofluoroscopic swallowing study (VFSS) or a fibre-optic endoscopic examination of swallowing (FEES), in particular in newborns and infants with neurological impairments. Lung ultrasound (LUS) has been proposed as a non-invasive, radiation-free tool for the diagnosis of pulmonary conditions in infants, with high sensitivity and specificity.

Methods: A RCT will be conducted in infants aged between 0 and 6 years having, or being at risk for, cerebral palsy, or other neurodevelopmental disease that determines abnormal muscular tone or motor developmental delay assessed by a quantitative scale for infants or if there is the suspicion of GERD or dysphagia based on clinical symptoms. Infants will be allocated in one of 2 groups: 1) LUS-monitored management (LUS-m); 2) Standard care management (SC-m) and after baseline assessment (T0), both groups will undergo an experimental 6-months follow-up. In the first 3 months, infants will be evaluated a minimum of 1 time per month, in-hospital, for a total of 3 LUS-monitored meal evaluations. Primary and secondary endpoint measures will be collected at 3 and 6 months.

Discussion: This paper describes the study protocol consisting of a RCT with two main objectives: (1) to evaluate the benefits of the use of LUS for monitoring silent and apparent aspiration in the management of dysphagia and its impact on pulmonary illness and growth and (2) to investigate the impact of the LUS management on blood sample and bone metabolism, pain and interaction with caregivers.

Trial registration: Trial registration date 02/05/2020; ClinicalTrials.gov Identifier: NCT04253951 .

Keywords: Aspiration; Dysphagia; GERD; Infant; Lung ultrasound (LUS); Neurological impairment.

Conflict of interest statement

Authors have no competing interests to declare.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Schedule of study enrolment, interventions, and assessments
Fig. 2
Fig. 2
LUS scanning scheme. Ten scanning areas are identified. ASR: anterior superior right; AIR: anterior inferior right; ASL: anterior superior left; AIL: anterior inferior left; LR. Lateral Right; LL: Lateral left; PSR: Posterior Superior Right; PIR: Posterior Inferior Right; PSL: Posterior Superior Left; PIL: Posterior Inferior Left

References

    1. Quitadamo P, Thapar N, Staiano A, et al. Gastrointestinal and nutritional problems in neurologically impaired children. Eur J Paediatr Neurol. 2016;20(6):810–815. doi: 10.1016/j.ejpn.2016.05.019.
    1. Srivastava R, Jackson WD, Barnhart DC. Dysphagia and gastroesophageal reflux disease: dilemmas in diagnosis and management in children with neurological impairment. Pediatr Ann. 2010;39(4):225–231. doi: 10.3928/00904481-20100318-07.
    1. Kuperminc MN, Gottrand F, Samson-Fang L, et al. Nutritional management of children with cerebral palsy: a practical guide. Eur J Clin Nutr. 2013;67(Suppl 2):S21–S23. doi: 10.1038/ejcn.2013.227.
    1. 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;10(1):18–24. doi: 10.1016/j.prrv.2008.10.003.
    1. Arvedson J, Rogers B, Buck G, et al. Silent aspiration prominent in children with dysphagia. Int J PediatrOtorhinolaryngol. 1994;28(2–3):173–181. doi: 10.1016/0165-5876(94)90009-4.
    1. Blackmore AM, Bear N, Blair E, et al. Factors Associated with Respiratory Illness in Children and Young Adults with Cerebral Palsy. J Pediatr. 2016;168:151–7.e1. doi: 10.1016/j.jpeds.2015.09.064.
    1. Pillai Riddell RR, Stevens BJ, McKeever P, et al. Chronic pain in hospitalized infants: health professionals’ perspectives. J Pain. 2009;10(12):1217–1225. doi: 10.1016/j.jpain.2009.04.013.
    1. Penagini F, Mameli C, Fabiano V, et al. Dietary Intakes and Nutritional Issues in Neurologically Impaired Children. Nutrients. 2015;7(11):9400–9415. doi: 10.3390/nu7115469.
    1. Romano C, van Wynckel M, Hulst J, et al. European Society for Paediatric Gastroenterology, Hepatology and Nutrition Guidelines for the Evaluation and Treatment of Gastrointestinal and Nutritional Complications in Children With Neurological Impairment. J Pediatr Gastroenterol Nutr. 2017;65(2):242–264. doi: 10.1097/MPG.0000000000001646.
    1. Dipasquale V, Gottrand F, Sullivan PB, et al. Top-ten tips for managing nutritional issues and gastrointestinal symptoms in children with neurological impairment. Ital J Pediatr. 2020;46:35. doi: 10.1186/s13052-020-0800-1.
    1. 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;54(9):784–795. doi: 10.1111/j.1469-8749.2012.04302.x.
    1. Engel-Hoek LV, Erasmus CE, Hulst KC, et al. Children with central and peripheral neurologic disorders have distinguishable patterns of dysphagia on videofluoroscopic wallow study. J Child Neurol. 2014;29:646–653. doi: 10.1177/0883073813501871.
    1. Calvo I, Conway A, Henriques F, et al. Diagnostic accuracy of the clinical feeding evaluation in detecting aspiration in children: a systematic review. Dev Med Child Neurol. 2016;58(6):541–553. doi: 10.1111/dmcn.13058.
    1. Cichero J, Nicholson T, Dodrill P. Liquid barium is not representative of infant formula: characterization of rheological and material properties. Dysphagia. 2011;26(3):264–271. doi: 10.1007/s00455-010-9303-3.
    1. Novak I, Morgan C, Adde L, et al. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017;171(9):897–907. doi: 10.1001/jamapediatrics.2017.1689.
    1. Uhm KE, Yi SH, Chang HJ, Cheon HJ, et al. Videofluoroscopic swallowing study findings in full-term and preterm infants with Dysphagia. Ann Rehabil Med. 2013;37(2):175–82. doi: 10.5535/arm.2013.37.2.175.
    1. Krasaelap A, Kovacic K, Goday PS. Nutrition Management in Pediatric Gastrointestinal Motility Disorders. Nutr Clin Pract. 2020;35(2):265–272. doi: 10.1002/ncp.10319.
    1. Volpicelli G, Elbarbary M, Blaivas M, et al. International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012;38(4):577–591. doi: 10.1007/s00134-012-2513-4.
    1. Raimondi F, Migliaro F, Sodano A, et al. Can neonatal lung ultrasound monitor fluid clearance and predict the need of respiratory support? Crit Care. 2012;16(6):R220. doi: 10.1186/cc11865.
    1. Raimondi F, Migliaro F, Sodano A, et al. Use of neonatal chest ultrasound to predict noninvasive ventilation failure. Pediatrics. 2014;134(4):e1089–e1094. doi: 10.1542/peds.2013-3924.
    1. Gargani L, Volpicelli G. How I do it: lung ultrasound. Cardiovasc Ultrasound. 2014;4(12):25. doi: 10.1186/1476-7120-12-25.
    1. Balk DS, Lee C, Schafer J, et al. Lung ultrasound compared to chest X-ray for diagnosis of pediatric pneumonia: A meta-analysis. Pediatr Pulmonol. 2018;53(8):1130-9.
    1. Brenner D, Elliston C, Hall E, Berdon W. Estimated risks of radiation-induced fatal cancer from pediatric CT. AJR Am J Roentgenol. 2001;176(2):289–296. doi: 10.2214/ajr.176.2.1760289.
    1. Saudi J Anaesth. The CONSORT statement. 2019;13(Suppl 1):S27-30. 10.4103/sja.SJA_559_18.
    1. Cantinotti M, Ait Ali L, Scalese M, et al. Lung ultrasound reclassification of chest X-ray data after pediatric cardiac surgery. Paedia Anaesth. 2018;28(5):421–427. doi: 10.1111/pan.13360.
    1. Romeo DM, Ricci D, Brogna C, et al. Use of the Hammersmith Infant Neurological Examination in infants with cerebral palsy: a critical review of the literature. Dev Med Child Neurol. 2016;58(3):240–245. doi: 10.1111/dmcn.12876.
    1. Snyder P, Eason JM, Philibert D, Ridgway A, McCaughey T. Concurrent validity and reliability of the Alberta Infant Motor Scale in infants at dual risk for motor delays. Phys Occup Ther Pediatr. 2008;28(3):267–282. doi: 10.1080/01942630802224892.
    1. Palisano R, Rosenbaum P, Bartlett D, et al. CanChild Centre for Childhood Disability Research, McMaster University. 2007.
    1. La prevenzione delle infezioni respiratorie ricorrenti - Consensus intersocietaria IRR 2020.
    1. O’Rourke D. The measurement of pain in infants, children, and adolescents: from policy to practice. PhysTher. 2004;84(6):560–570.
    1. Abidin RR. Parenting Stress Index-Fourth Edition (PSI-4) Lutz: Psychological Assessment Resources; 2012.
    1. Tucker K, Branson J, Dilleen M, et al. Protecting patient privacy when sharing patient-level data from clinical trials. BMC Med Res Methodol. 2016;16(Suppl 1):77. doi: 10.1186/s12874-016-0169-4.

Source: PubMed

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