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临床试验/NCT06417385
NCT06417385招募中不适用

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)-Paired Breastfeeding to Improve Breastfeeding at Discharge

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Adequate volume transfer during breastfeeding

研究概览

简要总结

Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve stimulation. Investigators will recruit 10 premature, ≥ 35 weeks gestational age, or convalescing sick term infants admitted to the NICU at MUSC to participate in this study. Infants will receive taVNS treatments once a day with breastfeeding's for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort, and during daily treatment paired with breastfeeding the infant will continue to receive this level of electrical stimulation, coinciding with latching and sucking, repeated over the duration of the feed. Investigators will collect information about the pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow techniques by the infant from parents and the lactation consultant. Investigators will also evaluate parental satisfaction associated with their infant's ability to breastfeed after taVNS by providing parental satisfaction surveys at the beginning, after 1 and 2 weeks, and at 3 months after the end of the study to assess infants' progress in and maintenance of breastfeeding abilities.

If the pairing of breastfeeding with taVNS is able to result in improved outcomes of effective breastfeeding in infants in the neonatal intensive care units, this intervention could be further utilized by NICUs to increase the rate of premature and sick term infants who are successfully able to breastfeed at the time of discharge and maintain breast feeding longer after discharge. This would allow premature infants to acquire the many benefits of breastmilk as well as contribute towards the strengthening of the maternal-infant bond that breastfeeding has been shown to enhance.

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

  • Infants ≥ 35 weeks post-menstrual age,
  • Clinically stable, without significant respiratory support,
  • Deemed safe to breastfeed by OT/SLP/lactation,
  • Maternal interest in breastfeeding,
  • Are not breastfeeding well despite the assistance of a lactation consultant.

排除标准

  • Cardiomyopathy,
  • Unstable bradycardia,
  • Significant respiratory support,
  • Absent maternal interest in breastfeeding, or infant or mother with contraindications to breastfeeding such as infantile galactosemia,
  • Maternal HIV without adequate viral suppression,
  • Maternal illicit drug use.

研究组 & 干预措施

taVNS treatment group

Experimental

All 10 infants will receive active taVNS during breastfeeding sessions. There is no randomization or blinding involved.

干预措施: taVNS soterix device (Device)

结局指标

主要结局

Adequate volume transfer during breastfeeding

时间窗: 2 weeks

Measured by pre- and post-feed weights (grams)

Infant's ability to sustain breastfeeding for a length of time

时间窗: 2 weeks

Average length of active feeding at the breast (minutes)

Targeted motor learning of skills involved in breastfeeding

时间窗: 2 weeks

Demonstration of successful latch, suck, and swallow techniques by the infant per LATCH scoring (L= latch, A= audible swallowing, T= type of nipple (inverted, flat, everted after stimulation), C= Comfort of mother during feed, H= Hold/positioning of infant), scoring 0-10 (2 points per question) with 10 being the highest and optimal score.

次要结局

  • Level of connectedness and social-emotional bond felt by mother towards infant assessed by study specific survey(2 months)
  • Frequency of breastfeeding assessed by study specific survey(2 months)
  • Parent satisfaction with infant's ability to breastfeed assessed by study specific survey(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haley Burdge

Medical/Dental Resident, Department of Pediatrics, Principal Investigator

Medical University of South Carolina

研究点 (1)

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