Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

Обзор

This study will examine the effects of varying liquid viscosity on swallow physiology in infants with oropharyngeal dysphagia and brief resolved unexplained event (BRUE) and other children with dysphagia that would be at risk for symptoms of swallow dysfunction.

Подробное описание

Infants with oropharyngeal dysphagia and in particular brief resolved unexplained events (BRUE) are a significant driver of pediatric health care expenditure since the mechanism for their swallow dysfunction is incompletely understood and therefore frequently goes unrecognized and untreated. We hypothesize that infants with oropharyngeal dysphagia and BRUE have measurable differences in swallowing physiology to explain their symptoms of cyanotic choking spells, that these differences can be quantified using pharyngeal high resolution impedance-manometry compared to videofluoroscopic swallow study results, and that this swallowing dysfunction can be safely corrected with a change of formula viscosity. Through this research project, we will systematically investigate the effects of thickened feedings on swallow function in infants with dysphagia and BRUE and perform detailed physiology studies on pharyngeal and esophageal motility as critical mediators of improved outcomes.

Вмешательства

• Пищевая добавка Thin liquid swallows
  Thin liquid swallows of formula or breastmilk or other liquid
• Пищевая добавка Slightly thickened liquid swallows
  Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
• Пищевая добавка Mildly thickened liquid swallows
  Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
• Пищевая добавка Moderately thickened liquid swallows
  Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Первичные конечные точки

• Swallow risk indices for thin vs mildly thick vs slightly thick liquids [Срок оценки: 30 minutes]

Вторичные конечные точки (1)

• Impedance-Manometry Swallow Physiology Metrics [Срок оценки: 30 minutes]

Критерии участия

Критерии включения

• Age 0 to 21 years
• Admitted to Boston Children's Hospital after experiencing first lifetime BRUE, or with dysphagia symptoms such that they would be at risk for BRUE or other symptoms of swallowing difficulty
• Have had videofluoroscopic swallow study performed or might have future videofluoroscopic swallow study performed.

Критерии исключения

• Any pre-existing medical diagnoses that exclude brief resolved unexplained event diagnosis including seizure disorders and cyanotic congenital heart disease
• Any nasal/pharyngeal/esophageal anomalies that might affect safe placement of the pharyngeal motility catheter
• Children fed exclusively by enteral tube
• Allergy to rice cereal or Gelmix thickener, which will be used to adjust liquid viscosity

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Boston Children's Hospital — Boston

Публикации

• Duncan DR, Amirault J, Mitchell PD, Larson K, Rosen RL. Oropharyngeal Dysphagia Is Strongly Correlated With Apparent Life-Threatening Events. J Pediatr Gastroenterol Nutr. 2017 Aug;65(2):168-172. doi: 10.1097/MPG.0000000000001439. PMID 27741062
• Duncan DR, Larson K, Rosen RL. Clinical Aspects of Thickeners for Pediatric Gastroesophageal Reflux and Oropharyngeal Dysphagia. Curr Gastroenterol Rep. 2019 May 16;21(7):30. doi: 10.1007/s11894-019-0697-2. PMID 31098722
• Duncan DR, Growdon AS, Liu E, Larson K, Gonzalez M, Norris K, Rosen RL. The Impact of the American Academy of Pediatrics Brief Resolved Unexplained Event Guidelines on Gastrointestinal Testing and Prescribing Practices. J Pediatr. 2019 Aug;211:112-119.e4. doi: 10.1016/j.jpeds.2019.04.007. Epub 2019 May 15. PMID 31103259
• Rommel N, Selleslagh M, Hoffman I, Smet MH, Davidson G, Tack J, Omari TI. Objective assessment of swallow function in children with suspected aspiration using pharyngeal automated impedance manometry. J Pediatr Gastroenterol Nutr. 2014 Jun;58(6):789-94. doi: 10.1097/MPG.0000000000000337. PMID 24552674
• Omari TI, Dejaeger E, Van Beckevoort D, Goeleven A, De Cock P, Hoffman I, Smet MH, Davidson GP, Tack J, Rommel N. A novel method for the nonradiological assessment of ineffective swallowing. Am J Gastroenterol. 2011 Oct;106(10):1796-802. doi: 10.1038/ajg.2011.143. Epub 2011 May 10. PMID 21556039
• Duncan DR, Liu E, Growdon AS, Larson K, Rosen RL. A Prospective Study of Brief Resolved Unexplained Events: Risk Factors for Persistent Symptoms. Hosp Pediatr. 2022 Dec 1;12(12):1030-1043. doi: 10.1542/hpeds.2022-006550. PMID 36336644

Идентификаторы

NCT: NCT04504227 · IRB-P00036103 · K23DK127251

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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