Safety and Feasibility of Aerodigestive Stimulation Therapy in Infants With Complex Feeding Difficulties
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Oral feeding volumes prior to and at the completion of the study
研究概览
简要总结
The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. The main aims are:
- To provide consistent activation of deglutition (the process of swallowing), swallowing-airway interactions, and peristalsis in order to decrease the risk of home tube feeding.
- To examine whether physical and manometric evidence-guided interventions and biofeedback will improve compliance, minimize parental stress, and increase satisfaction and perceived self-confidence with infant feeding.
Participants will have weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) for 4 weeks or until discharge, oral nutritive stimulation of at least 5 mL of prescribed milk with each feed, and weekly parental education and feedback regarding feeding progress.
详细描述
Stimulation will be provided to the esophagus using esophageal manometry starting at enrollment and then weekly for 4 weeks or until discharge, whichever occurs first. During the 4 weeks of study enrollment, subjects will also be provided nutritive oral feeding therapy with each care with a minimum of 5 mL of their prescribed feed. Feeding evaluations by a study team member will occur once a day during the length of the 4-week trial. The study team will do weekly rounds at the bedside to evaluate feeding progress and study interventions. A feeding plan will be posted at the bedside for clear communication with the care team and family of the subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NICU infant ≥37 weeks postmenstrual age not taking full oral feeds
- •Consult to Neonatal & Infant Feeding Disorder Program for oral feeding difficulty with diagnostic manometry ordered
- •Presence of peristaltic and sphincteric reflexes at initial manometry
排除标准
- •Potentially lethal chromosomal anomalies
- •Craniofacial malformations
- •Foregut malformations
研究组 & 干预措施
Infants with Complex Feeding Difficulties
Weekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy
干预措施: Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy (Procedure)
结局指标
主要结局
Oral feeding volumes prior to and at the completion of the study
时间窗: Collected at 4 weeks or prior to discharge
Oral feeding volume will be compared prior to the initial manometry study and after the completion of the final manometry study after 4 weeks or prior to discharge, whichever is earliest
Parent surveys
时间窗: 4 weeks or prior to discharge
Parental questionnaires will be compared from prior to initial esophageal manometry study and after completion of final esophageal manometry study.
次要结局
未报告次要终点
研究者
Sudarshan Jadcherla
Principal Investigator, Innovative Feeding Disorders Research Program
Nationwide Children's Hospital