跳至主要内容
临床试验/NCT04504227
NCT04504227招募中不适用

Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Swallow risk indices for thin vs mildly thick vs slightly thick liquids

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Thin liquid swallows

Placebo Comparator

Thin liquid swallows of formula or breastmilk or other liquid

干预措施: Thin liquid swallows (Dietary Supplement)

Slightly thick liquid swallows

Experimental

Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

干预措施: Slightly thickened liquid swallows (Dietary Supplement)

Mildly thick liquid swallows

Experimental

Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

干预措施: Mildly thickened liquid swallows (Dietary Supplement)

Moderately thick liquid swallows

Experimental

Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

干预措施: Moderately thickened liquid swallows (Dietary Supplement)

结局指标

主要结局

Swallow risk indices for thin vs mildly thick vs slightly thick liquids

时间窗: 30 minutes

We will calculate swallow risk index (SRI) from impedance-manometry results to compare mean SRI with thin liquids and thickened liquids for subjects with aspiration compared to mean SRI for thin liquids and thickened liquids in subjects without aspiration.

次要结局

  • Impedance-Manometry Swallow Physiology Metrics(30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Duncan

Assistant Professor of Pediatrics

Boston Children's Hospital

研究点 (1)

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