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Идёт набор NCT06417385

taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

Без фазы С лечением Premature Birth Breastfeeding, Exclusive Feeding; Difficult, Newborn

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: taVNS soterix device.
Кому может быть актуально
Состояния в реестре: Premature Birth, Breastfeeding, Exclusive, Feeding; Difficult, Newborn. Базовые параметры: от 35 Weeks · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство taVNS soterix device
    Soterix is a custom modified, FDA-cleared electrical stimulator that meets the criteria of the FDA for investigational use. Neoleads will be placed in order to deliver electrical stimulation using microcurrent (\<2.5mA) with breastfeeding, on with sucking and swallowing and off with rest for 5 feeds per week for 2 weeks.

Первичные конечные точки

  • Adequate volume transfer during breastfeeding [Срок оценки: 2 weeks]
  • Infant's ability to sustain breastfeeding for a length of time [Срок оценки: 2 weeks]
  • Targeted motor learning of skills involved in breastfeeding [Срок оценки: 2 weeks]
  • Targeted motor learning of skills involved in breastfeeding [Срок оценки: 2 weeks]
Вторичные конечные точки (3)
  • Frequency of breastfeeding assessed by study specific survey [Срок оценки: 2 months]
  • Parent satisfaction with infant's ability to breastfeed assessed by study specific survey [Срок оценки: 2 months]
  • Level of connectedness and social-emotional bond felt by mother towards infant assessed by study specific survey [Срок оценки: 2 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Medical University of South Carolina Shawn Jenkins Children's Hospital — Charleston

Идентификаторы

NCT: NCT06417385 · Pro00131771

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗