BabyStrong taVNS-Paired Bottle Feeding to Improve Oral Feeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Bradycardia
研究概览
简要总结
Feeding is critical for pre-term infants and term infants with hypoxic ischemic brain injury, in order to be discharged home with their families and avoid a gastrostomy tube (G-tube) placement. The proposed study will employ a novel system that stimulates the vagus nerve through the skin in front part of the ear, the BabyStrong feeding system, to delivered transcutaneous auricular vagus nerve stimulation (taVNS) paired with oral feedings daily for 10 days. In an earlier study at Medical University of South Carolina (MUSC), this type of vagus nerve stimulation resulted in more than half of infants who were slated to receive G-tubes, taking full oral feeds by mouth and avoiding a G-tube. In this study some babies will receive the therapy for 10 days and others will get no stimulation. If no progress is made in feeding volumes by day 10, the infants will be switched to the other treatment for 7 days. Parents, study personnel, and care providers will be blinded to taVNS assignment. The electronic stimulation device is Federal Drug Administration (FDA)-cleared for investigational use, and the BabyStrong has been designated a Breakthrough Medical Device by the FDA. This study will be conducted in MUSC's Neonatal Intensive Care Unit.
详细描述
In this Phase I study, we will conduct a small-scale safety and feasibility study of 2 different taVNS units and ear electrode positions to optimize the BabyStrong portable taVNS feeding system and test the study design of randomization for 10 days. We will test the BabyStrong feeding system using up to n=10 active and n=10 sham taVNS in infants with twice daily treatment for 10 days, with cross over to alternate treatment for another 7days if there is no progress with feeds (increase <4ml/kg/d). G-tube placement will be arranged if infant continues to make no progress. If the infant attains full oral feeds and gains weight, they may be discharged at any time during the treatment protocol. The treatment assignment will be blinded to care providers, study personnel and parents. We will compare the number of participants who attain full oral feeds (= or > 130ml/kg/d with weight gain). Safety measures will be bradycardia and discomfort.
Criteria for success of BabyStrong feeding system: No sustained increase in discomfort scores; No bradycardia; attainment of full oral feeds in 50% of infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
blinded to study treatment assignment to active or sham taVNS. Perceptual threshold (PT) will be determined in both treatment groups.
入排标准
- 年龄范围
- 2 Weeks 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at any gestational age (GA), failing oral feeds after trying to learn feeding for 2 weeks if term, and 4 weeks if preterm
- •safe to attempt oral feeds every feed without volume limitations by occupational or speech therapists, and
- •clinical team is considering the need for a G-tube.
排除标准
- •cardiomyopathy
- •unstable bradycardia
- •significant respiratory support
- •infants of poorly controlled diabetic mothers, defined by obstetrical care providers, HgbA1C>5.6% or ketonuria.
结局指标
主要结局
Bradycardia
时间窗: 30 minutes during taVNS paired-feed for 10 days
safety : number of participants with episode of Heart rate \< 80beats per minute for 5 seconds, according to the first assigned treatment
Discomfort Scores
时间窗: 30 minutes during taVNS paired-feed up to 17 days
mean number of participants with Neonatal and Infant Pain scale (NIPS) \>3 point increase, indicating worse discomfort according to the first assigned treatment
Participants Who Attain Full Oral Feeds
时间窗: 17 days
taVNS in participants who received tragus stimulation and attained full oral feeds (oral intake = or \>130ml/kg/day with weight gain) according to the first assigned treatment
次要结局
未报告次要终点