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Идёт набор NCT06563726

Sodium Awareness in Lactation Trial

Без фазы С лечением Breastfeeding Preterm Birth Breast Pumping Lactation; Insufficient, Partial

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: point-of-care milk sodium testing.
Кому может быть актуально
Состояния в реестре: Breastfeeding, Preterm Birth, Breast Pumping, Lactation; Insufficient, Partial. Базовые параметры: Без ограничений · Женщины.
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

Partnering With Parents for Pumping Success: Feasibility of Personalized Lactation Support Utilizing Point-of-Care Human Milk Biomarkers

Обзор

SALT is a multi-centre, non-blinded, non-randomized prospective interventional pilot study teaching lactating parents of hospitalized preterm infants how to test their breastmilk sodium (Na) using point-of-care (POC) meters. A drop in Na is a sign of secretory activation in the breast that is associated with adequate short and long-term breast milk volumes in this vulnerable population. Primary Objective: Establish feasibility, acceptance, and time cost of parent-led parent milk Na testing in the first 14 days postpartum Secondary Objective: Further investigate relationships between pumping behaviours, lactation risk factors, daily milk Na and lactation outcomes Exploratory Objective: Explore how POC Na data may be used to modify pumping behaviour and milk volumes

Вмешательства

  • Диагностический тест point-of-care milk sodium testing
    Data-driven interventions to improve early lactation success are lacking, and parents who deliver preterm are at high risk of lactation challenges. We will be studying feasibility, acceptability, and time cost of teaching lactating parents of hospitalized preterm infants how to test their breastmilk sodium (Na) using point-of-care (POC) meters. As a secondary aim, we will assess the potential to use these POC sodium results to guide personalized lactation care in the form of altered pumping sche

Первичные конечные точки

  • Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: economic [Срок оценки: First 14 days postpartum]
  • Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via interviews [Срок оценки: First 14 days postpartum]
  • Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via surveys [Срок оценки: First 14 days postpartum]
Вторичные конечные точки (2)
  • Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na levels and longer term lactation outcomes (milk provision at NICU discharge). [Срок оценки: Enrollment to infant NICU discharge, up to 52 weeks (average NICU stay is about 10 weeks)]
  • Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na and short term lactation outcomes (coming to volume) [Срок оценки: First 14 days postpartum]

Критерии участия

Критерии включения

  • Consent provided
  • Have delivered a preterm singleton or twin infant at <35 weeks gestation admitted to a study NICU at birth or transferred into a study NICU from another NICU within the first 72 hours postpartum
  • Day 5 or less postpartum (Day 1 = day of delivery) upon enrollment (ideally day 3 or less)
  • Plans to lactate at least 2 weeks and initiate lactation with a breast pump
  • Expected infant NICU stay of 7+ (ideally 14+) days in enrollment NICU(s)

Критерии исключения

  • Potential study participant's infant is critically ill and not expected to survive or has lethal diagnosis with plans by medical team/family to redirect care
  • Has delivered triplets or higher order multiples (potential confounder for lactation challenges; of note, triplets or higher are rare, on the order of a few parents annually)
  • Lactation contraindication(s) (i.e., active chemotherapy) or declines lactation initiation
  • History of breast surgery that may affect ability to lactate (i.e., breast reduction; breast augmentation that utilized nipple incisions)
  • Using or planning to use hormonal birth control in the first 14 days post-partum as may affect secretory activation/lactation
  • Unable/unwilling to be present in study NICU during any of first 5 days postpartum
  • Presumption by the medical team that infant will be in study NICU for <5 days

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 2 центра
  • Seattle Children's Hospital — Seattle
  • University of Washington Medical Center - Montlake — Seattle

Идентификаторы

NCT: NCT06563726 · PJM-185757

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗