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Набор скоро начнётся NCT06127914

Learning Early Infant Feeding Cues

Без фазы С лечением Responsive Feeding Infants Weight Gain Trajectory

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: Learning Early Infant Feeding Cues.
Кому может быть актуально
Состояния в реестре: Responsive Feeding, Infants, Weight Gain Trajectory. Базовые параметры: от 2 Weeks · 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multiphase Project to Improve Use of Responsive Feeding Among Vulnerable Mother-Infant Dyads

Обзор

The goal of this clinical trial is to learn more about responsive infant feeding (recognizing baby's signs of hunger and fullness) in mothers and infant enrolled in government-funded maternal-child home visiting programs. The main questions it aims to answer are: * What are the contributors and barriers to use of responsive infant feeding? * How can we refine an intervention focused on responsive infant feeding (the Learning Early Infant Feeding Cues intervention) so that mothers will like it and learn skills to help their baby be healthy. * Will the refined intervention improve use of responsive feeding and be feasible and acceptable to mothers and home visiting programs? Participants will be asked to: * Participate in focus groups to talk about their experiences feeding their baby. * Participate in a study to learn about responsive feeding and how to use it with their baby. This study will start when mothers are in their final month of pregnancy and finish when their baby is 6 months old. Participation will include: * Having someone come to the family home during a time when the baby is eating (either from the breast or the bottle). The mother will receive information on the baby's signs from an experienced coach. * Agreeing to be video recording during the session when the baby is eating. * Completing surveys online.

Вмешательства

  • Поведенческое Learning Early Infant Feeding Cues
    The LEIFc intervention includes individualized responsive feeding education and promotion using the SS-OO-PP-RR (or "super," Setting the Stage, Observation and Opportunities to Embed, Problem Solving and Planning, Reflection and Review coaching approach as a guide. An interventionists interacts with mother-infant dyads during a feeding session at infant ages of 1, 2, 3, 4, and 5 months and coaches the mother on responsive feeding. In particular infant cues of hunger and fullness and tips to assi

Первичные конечные точки

  • Responsive Feeding [Срок оценки: Pre (infant age of 2 weeks) and post (infant age of 6 weeks) intervention.]
Вторичные конечные точки (3)
  • Infant growth trajectory [Срок оценки: Infant age of 2 weeks to 6 months.]
  • Age of complementary food introduction [Срок оценки: weeks or months since birth]
  • Duration of any breastfeeding [Срок оценки: weeks or months since birth]

Критерии участия

Maternal Inclusion Criteria

  • Pregnant mother in the 3rd trimester (28 weeks or beyond)
  • Enrolled in a government-funded maternal-child home visiting program
  • Maternal age 18 years or older
  • English or Spanish speaking
  • Anticipated to have custody of infant after birth
  • Healthy pregnancy, no complications that are anticipated to result in a preterm birth or extended hospital stay for mother or infant

Maternal Exclusion Criteria

  • Gave birth to multiple fetuses
  • Age less than 18 years
  • Not fluent in English or Spanish
  • Expected to not have custody of the infant after birth

Infant inclusion criteria

  • Born as a singleton (not a twin, triplet, etc.) to a mother enrolled in a maternal-child home visiting program
  • Born full term (37 weeks or beyond)

Infant exclusion criteria

  • Congenital anomaly that may interfere with infant feeding or growth after birth (i.e., Down Syndrome, cleft lip/palate)
  • Born preterm (born prior to 37 weeks)
  • NICU stay beyond 48 hours
  • Infant diagnosis of failure to thrive
  • Supplemental oxygen
  • Enteral feeding device used for feedings

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
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Bahorski J, Romano M, McDougal JM, Kiratzis E, Pocchio K, Paek I. Development of an Individualized Responsive Feeding Intervention-Learning Early Infant Feeding Cues: Protocol for a Nonrandomized Study. JMIR Res Protoc. 2023 Feb 28;12:e44329. doi: 10.2196/44329. PMID 36853761

Идентификаторы

NCT: NCT06127914 · STUDY00004685

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗