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临床试验/NCT02583360
NCT02583360已完成不适用

Neonatal Esophagus and Airway Interactions in Health and Disease

Sudarshan Jadcherla2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2015年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
109
试验地点
2
主要终点
Number of Participants With Successful Safe Oral Feeding

研究概览

简要总结

The purpose of the investigator's study is to evaluate the causes of feeding difficulty in infants. New treatments can be possible only if the cause is known. In this study, the investigator plans to evaluate the movement of the muscles in an infant's mouth, throat (pharynx) and food pipe (esophagus) that are responsible for moving the food down into the stomach and that help protect an infants airway.

详细描述

Infants with chronic feeding difficulties exhibit inadequacy of suck-swallow and breathe coordination, regurgitation or vomiting, gastroesophageal reflux disease, and airway aspiration. Often these infants must rely on feeding tubes, either inserted through the nose or surgically placed, to meet their nutrition and hydration needs until they are able to orally feed safely, effectively, and efficiently. The process of assessment and treatment of swallowing disorders is often stressful for the infants and their providers, including parents. The goal of this study is to combine two commonly used diagnostic techniques (video fluoroscopy swallow studies and esophageal manometry) to more comprehensively evaluate feeding from the mouth to the stomach in infants. The hope is that by doing so treatment strategies can be improved.

: Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy. The data is from single center prospective observational study. The controls are those who had VFSS alone with provider recommendations from the same single center.

In addition, we are also embarking on alternate strategies to achieve the original stated aims: 1) Mechanisms of dysphagia is ascertained by studying concurrent recordings of VFSS and manometry. 2) Feeding outcomes of Dysphagic infants are ascertained by evaluating the discharge outcomes and 1-year feeding outcomes among those that had evaluation of dysphagia using VFSS. 3) Dysphagic infants that had sequential VFSS and manometry studies are evaluated to test which method is a better predictor of stated outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
38 Weeks 至 60 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Infants with feeding-related aero-digestive symptoms
  • ≤60 weeks PMA (both pre-term and full term)
  • History of orally feeding ≥ 25% of least 50% of prescribed feeding volume
  • Room air or supplemental oxygen of ≤1liter/minute (LPM)

排除标准

  • Direct breast feeding exclusively
  • Known genetic, metabolic or syndromic disease
  • Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH), moderate to severe perinatal asphyxia or stroke
  • Craniofacial, airway or foregut malformations
  • History of craniofacial, foregut, ears, nose and throat (ENT) or neurosurgery

结局指标

主要结局

Number of Participants With Successful Safe Oral Feeding

时间窗: Up to 4 weeks after enrollment

The primary endpoint is the feeding success defined as full oral feeding (no tube feeds feeds) without symptoms that require interventions

次要结局

  • Hospital Length of Stay From Admission to Discharge in Days(from hospital admission until discharge)
  • Weight Growth Velocity in Grams/Day(4 weeks)

研究者

发起方
Sudarshan Jadcherla
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sudarshan Jadcherla

Principal Investigator

Nationwide Children's Hospital

研究点 (2)

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