Randomized Treatment of Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Increased percent of subjects towards achieving full oral feedings earlier in the subject's dysphagia treatment.
研究概览
简要总结
The purpose of this study is to evaluate if the use of Neuromuscular Electrical Stimulation (NMES) will provide a more efficient method of treating neonates with dysfunctional oral feeding such as dysphagia. This study will attempt to determine if NMES applied to neonates at 36-42 weeks post-conception age (PCA) will decrease the need for nasogastric tubes (NG) and gastrostomy tubes (G-TUBE). Increase the rate at which these neonates complete full oral feeds, improve their swallowing skills, increase oral intake of calories, and gain weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 36 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female.
- •Meet diagnostic criteria for dysphagia symptoms using the NOMAS and a VFSS.
- •Infants with intraventricular hemorrhage (IVH) and hypoxic events can be included.
- •Infants taking less than 5-10% of target volume by mouth between the ages of 36-42 weeks PCA.
- •Multiple swallows to clear bolus following suck that includes a desaturation <80% and bradycardia <80 bpm.
- •Apnea spells during feeds.
- •Aspiration or penetration by VFSS
排除标准
- •Known neurologic or neurodegenerative disorders.
- •Chromosomal anomalies and syndromes.
- •Cleft lip or palate.
- •Birth defects.
- •Unresolved cutaneous rash at the area of electrode placement.
- •Medical condition that is a contraindication to NMES.
研究组 & 干预措施
VitalStim
This group will be assigned to the active VitalStim unit.
干预措施: VitalStim (Device)
Sham VitalStim
This group will be assigned to the sham VitalStim unit.
干预措施: Sham VitalStim (Device)
结局指标
主要结局
Increased percent of subjects towards achieving full oral feedings earlier in the subject's dysphagia treatment.
时间窗: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
Earlier NG tube removal for the treatment group compared to the control group.
时间窗: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
Increase the amount of formula volume taken at feedings from beginning to end of study.
时间窗: 2 weeks
Reduction in G-tube rate insertions for the treatment grouped compared to the sham group.
时间窗: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
次要结局
- Decrease inpatient length of stay.(4 weeks)
- Decrease spells with oral feeds over the course of the study.(2 weeks)
- Allow for healthy weight gain via improved feedings.(2 weeks)
- Increase the caloric intake orally.(2 weeks)
- Decrease the oxygen requirement before and after study.(2 weeks)
- Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet.(2 weeks)