Меню
Идёт набор NCT04821544

Maternal Stress on Human Milk and Infant Outcomes

Без фазы С лечением Postpartum Depression Preterm Labor

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: Mindfulness-based intervention (with a focus on self-compassion; MBSC), Vitamin D.
Кому может быть актуально
Состояния в реестре: Postpartum Depression, Preterm Labor. Базовые параметры: 18 лет — 50 лет · 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Maternal Stress on Human Milk Composition and Subsequent Infant Outcomes

Обзор

The overarching purpose of this study is to determine if a modified 8-week mindfulness-based intervention (with a focus on self-compassion; MBSC) or 8 weeks of 2000 IU vitamin D supplementation will reduce stress and increase self-compassion in mothers of preterm infants and beneficially modify the human milk produced, and subsequently improve infant health.

Подробное описание

During every two-week period, newly admitted infants (both preterm \<37 weeks gestational age and term ≥37 weeks gestational age) at performance site Kootenai Health NICU and term infants from the Palouse region will be block randomized to control (standard of care), mindfulness intervention (modified 8-week mindfulness

-based intervention (with a focus on self-compassion; MBSC), or vitamin D supplementation (8-week 2,000 IU vitamin D3 supplementation) groups. The purpose of the nested cohorts is to minimize the postpartum time difference among cohort mothers. Each nested MBSC cohort will undergo the 8-week MBSC intervention with a focus on increasing self-compassion. The MBSC program includes previously developed daily mindfulness practices, guided meditations, routine mindfulness prompts, and four video conference group sessions with a certified mindfulness facilitator.

Maternal data: The Perceived Stress Scale (PSS) and Self-Compassion Scale-Short Form (SCS-SF) will be given to mothers from both groups pre- and post-intervention, and during the 4th week. Saliva, urine, stool, and human milk samples will be collected at the same time points as above. Additional maternal data include: age, race, height, weight (pre-pregnancy and last weight before delivery), parity, delivery mode, chorioamnionitis, preeclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelet) syndrome, antenatal antibiotics, anti-depressants or other mood-altering/neurochemical medications (current and during pregnancy), diagnosis of depression or other mental illness within the previous 5 years, history of postpartum depression and postpartum psychosis, diabetes, hypertension, heart disease, and any inflammatory or autoimmune diseases.

Infant data: Gestational age, birth weight, ventilation requirement, surgical interventions, patent ductus arteriosus, growth, nutrition prescriptions, saliva, urine and stool samples.

Data collection: All data (not including biosamples) will be collected using REDCap hosted within the UI system.

Sample measurements: Maternal salivary cortisol (marker of stress) and oxytocin (marker of anxiety and "social-closeness") concentrations will be measured using ELISA. Human milk proteins will be identified using mass spectrometry-based proteomics. Following proteomic analyses, targeted proteins will be quantified using ELISA and Western Blot. Both maternal and infant saliva, urine and stool samples will be used for metabolomic and transcriptomic sequencing to identify metabolic and molecular changes, respectively, in both mothers and infants. Infant systemic oxidative stress will be measured through urine F2-isoprostanes concentrations (ELISA), and infant intestinal inflammation will be determined with stool calprotectin concentrations (ELISA).

Вмешательства

  • Поведенческое Mindfulness-based intervention (with a focus on self-compassion; MBSC)
    8-week MBSC intervention with a focus on increasing self-compassion
  • Пищевая добавка Vitamin D
    Vitamin D at 2,000 IU/day for 8 weeks.

Первичные конечные точки

  • Maternal Stress - Biomarker Change [Срок оценки: Baseline to 4 and 8 weeks]
  • Maternal Stress - Psychometric Measure Change [Срок оценки: Baseline to 4 and 8 weeks]
  • Maternal Self-compassion - Biomarker Change [Срок оценки: Baseline to 4 and 8 weeks]
  • Maternal Self-compassion - Psychometric Measure Change [Срок оценки: Baseline to 4 and 8 weeks]
Вторичные конечные точки (4)
  • Human Milk Proteins & Peptides Change [Срок оценки: Baseline to 4 and 8 weeks]
  • Maternal Metabolomic & Transcriptomic Changes [Срок оценки: Baseline to 4 and 8 weeks]
  • Infant Metabolomic & Transcriptomic Changes [Срок оценки: Baseline to 4 and 8 weeks]
  • Maternal Vitamin D Changes [Срок оценки: Baseline to 4 and 8 weeks]

Критерии участия

Критерии включения

  • Mothers of newborn infants at Kootenai Health NICU and the Palouse region

Критерии исключения

\-

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Kootenai Health — Coeur d'Alene

Идентификаторы

NCT: NCT04821544 · 20-024 · 5U54GM104944-08 · P20GM152304

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗