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临床试验/NCT04421482
NCT04421482已完成不适用

Cold Milk as a Novel Therapy for Dysphagia in Preterm Infants

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Axillary Temperature of Infants Post Room Temperature Feeding

研究概览

简要总结

It is estimated that 30-70% of very low birth weight (VLBW) preterm infants will be diagnosed with swallowing dysfunction (dysphagia), which often leads to airway compromise in the form of laryngeal penetration and/or tracheal aspiration during oral feeding attempts. Chronic airway compromise results in a persistent inflammatory state, with disease progression that can be devastating for already fragile and developmentally immature lungs in preterm infants. At this time, there are limited therapeutic options for dysphagia in VLBW infants during oral feeding. In a recent publication, our research group was the first to demonstrate that short-duration of oral feeding with cold liquid reduces dysphagia occurrence from 71% to 26%. However, these data must be further validated for the effectiveness and safety of a full duration feeding before being recommended for routine clinical practice.

The objective is to identify preliminary evidence for the efficacy and safety of feeding full oral cold milk for dysphagia management in preterm infants. We hypothesize that oral feeding of cold milk in VLBW preterm infants with dysphagia will improve suck/swallow/breathe coordination and decrease penetration/ aspiration to the airway. We further hypothesize that cold milk intervention will have no adverse effects on intestinal blood flow, as assessed by Doppler Ultrasound. This is significant because there is a critical need to identify effective and safe evidence-based treatment options for dysphagia management in preterm infants.

This prospective study will seek to enroll Subjects who meet the following inclusion criteria: 1) VLBW (birth weight less than 1,500g and less than 32 weeks gestation), 2) admitted to NYU-Winthrop Neonatal Intensive Care Unit (NICU), 3) Post-menstrual age (PMA) > 35 weeks at the time of the study, 4) receiving no or minimum respiratory support (<1 lit/min low-flow nasal cannula), 5) tolerating at least 50% of their enteral feeding orally, 6) having symptoms of swallowing dysfunction during oral feeding (clinical dysphagia) and 7) referred by the medical team for video fluoroscopic swallow study (VFSS) and/or fiberoptic endoscopic evaluation of swallowing (FEES).

To assess the efficacy of cold milk in treating dysphagia, study subjects will first have an oral motor feeding assessment using an FDA approved device called the nFant® Feeding Solution as well as VFSS and/or FEES. To assess the safety of using cold milk, subjects will receive a doppler ultrasound before and after the ingestion of cold liquid feeding to assess the mesenteric blood flow.

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
35 Weeks 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Viable preterm infants less than 34 weeks gestation
  • admitted to NYU- Langone Long Island Hospital NICU
  • PMA > 35 weeks at the time of the study
  • receiving no or minimum respiratory support (<2 lit/min low-flow nasal cannula)
  • tolerating at least 50% of their enteral feeding orally and
  • having symptoms of swallowing dysfunction during oral feeding (clinical dysphagia).
  • referred by the medical team for VFSS and/or FEES assessments.

排除标准

  • Infants with other comorbidities, such as IUGR, upper airway anomalies, brain injury, neuromuscular disease, or life-threatening congenital disease.

结局指标

主要结局

Axillary Temperature of Infants Post Room Temperature Feeding

时间窗: Post feeding (up to 5 minutes)

Outcome measure will be assessed by measuring Axillary temperatures. The axillary temperature will be taken directly after feeding.

Percentage of Infants With Change in Vital Signs Due to Cold Milk

时间窗: 24 hours

Outcome measure will be assessed by monitoring changes in respiratory rate, heart rate, and oxygen saturation.

Percentage of Infants With Improvement of Dysphagia

时间窗: 15-20 minutes post cold milk feeding

Dysphagia will be assessed by Video Fluoroscopic Swallow Study (VFSS) and/or Fiberoptic Endoscopic Evaluation of Swallowing (FEES). If the infants showed signs of dysphagia they would receive cold cold milk and improvements in dysphagia would be assessed again by VFSS and FEES.

Change in Peak Systolic Velocity (PSV) (60 Minutes Post Feeding)

时间窗: Baseline (prior to feeding), 60 minutes after feeding

Outcome measure will be assessed by abdominal ultrasound. Peak systolic velocity (PSV) was measured for each patient before feeding (room temp or cold milk) as well as 60 minutes after feeding (room temp and cold milk).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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