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Идёт набор NCT05767658

Support Via Online Social Networks to Promote Safe Infant Care Practices

Без фазы С лечением Breastfeeding Infant Death Sudden Infant Death Syndrome Without Mention of Autopsy

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: Safe Sleep, Breastfeeding, Early Brain Development and Parent-Child Relationships.
Кому может быть актуально
Состояния в реестре: Breastfeeding, Infant Death, Sudden Infant Death Syndrome Without Mention of Autopsy. 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

Support Via Online Social Networks to Promote Safe Infant Care Practices Toward Reducing Racial Disparities in Infant Mortality

Обзор

This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF); and reduce Black/White disparities in these practices through the use of private Facebook groups providing a) evidence-based education through videos and other multi-media supporting best practices and b) an online community and social network of other pregnant WIC clients and new parents.

Вмешательства

  • Поведенческое Safe Sleep
    Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for infant safe sleep and b) an online community and social network of other pregnant WIC clients and new parents.
  • Поведенческое Breastfeeding
    Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for breastfeeding and b) an online community and social network of other pregnant WIC clients and new parents.
  • Поведенческое Early Brain Development and Parent-Child Relationships
    Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for early brain development and parent-child interactions (control intervention) and b) an online community and social network of other pregnant WIC clients and new parents.

Первичные конечные точки

  • Exclusive infant supine sleep position in the previous two weeks [Срок оценки: Between 2 and 6 months]
  • Infant sleep location (exclusive room sharing without bed sharing) in the previous two weeks [Срок оценки: Between 2 and 6 months]
  • Soft bedding use in the previous two weeks [Срок оценки: Between 2 and 6 months]
  • Breastmilk feeding in the previous two weeks [Срок оценки: Between 2 and 6 months]
Вторичные конечные точки (3)
  • Usual infant sleep position in the previous two weeks [Срок оценки: Between 2 and 6 months]
  • . Usual infant sleep location in the previous two weeks [Срок оценки: Between 2 and 6 months]
  • Pacifier use in the previous two weeks [Срок оценки: Between 2 and 6 months]

Критерии участия

Критерии включения

  • Currently enrolled in WIC, or it not, then have either Medicaid or no health insurance
  • Must be English speaking
  • Must be pregnant and less than 30 weeks gestation
  • Must live in the United States
  • Must have regular access to Facebook and short message service (SMS) texting (mobile phone)

Критерии исключения

  • Not planning to live in same home as infant after birth.
  • Prenatal diagnosis expected to impact on infant care practices in a manner not compatible with study goals, including contraindications to feeding any breastmilk or supine infant sleep positioning.
  • Known or reported mental health or other issues that would preclude custody of the infant or being able to participate in the informed consent process.
  • Meets the definition of a minor according to applicable state law.
  • Participants who consent to participation in the study, must complete the Agile Onboarding process before they reach 30+0 weeks gestation.
  • Currently or previously received a TodaysBaby educational program (randomized to a TodaysBaby program through either the SMARTER, or SUPERSONIC study), either in their current or a previous pregnancy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Boston University Medical Campus — Boston

Публикации

  • Carlin RF, Parker MG, Kellams AL, Hauck FR, Kerr S, Cornwell BT, Kiviniemi MT, Geller N, Boguszewski KE, Corwin MJ, Colson ER, Moon RY. Delivering safe sleep and breastfeeding education to pregnant and new mothers through private Facebook groups: study protocol for a 4-armed randomized controlled trial. BMC Pediatr. 2026 Apr 22;26(1):528. doi: 10.1186/s12887-026-06900-9. PMID 42021196

Идентификаторы

NCT: NCT05767658 · H-43455 · 5R01MD007702-07

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗