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Идёт набор NCT07665983

The Bottle Optimization Testing Tiny Little Eaters Study

Без фазы С лечением Childhood Obesity

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: Feeding.
Кому может быть актуально
Состояния в реестре: Childhood Obesity. Базовые параметры: от 4 мес. · 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

Managing Excess Infant Energy Intake by Increasing Satiation Responsiveness in Dyadic Feeding Interactions

Обзор

The researchers will study how babies respond to bottle nipples with different flow rates over a few days, and how this may affect how much milk they drink, their feeding patterns, and their sleep.

Подробное описание

The study will enroll 220 mother-infant dyads.

Вмешательства

  • Поведенческое Feeding
    Following a baseline day (Day 1) in which infants are fed with their typical nipple, infants are exposed to a commercially available nipple with a 30 percent reduced flow rate for three consecutive days (Days 2-4).

Первичные конечные точки

  • Change in milk/formula intake (Δ^(S-T)) [Срок оценки: From baseline to the end of the slower flow feeding phase (approximately 4 days later)]
Вторичные конечные точки (7)
  • Change in suck effect (Δ^(S-T)) [Срок оценки: From baseline to the end of the slower flow feeding phase (approximately 4 days later)]
  • Change in peak tongue pressure ((Δ^(S-T)) [Срок оценки: From baseline to the end of the slower flow feeding phase (approximately 4 days later)]
  • Change in sucking frequency (Δ^(S-T)) [Срок оценки: From baseline to the end of the slower flow feeding phase (approximately 4 days later)]
  • Change in sucking smoothness ((Δ^(S-T)) [Срок оценки: From baseline to the end of the slower flow feeding phase (approximately 4 days later)]
  • Change in feeding Interval for each of the 12-hour segments post-introduction of the Slower-Flow bottle nipple [Срок оценки: From baseline to the end of the slower flow feeding phase (approximately 4 days later)]
  • Change in satiation signaling (Δ^(S-T)) [Срок оценки: From baseline to the end of the slower flow feeding phase (approximately 4 days later)]
  • Change in dyadic mutuality between infant and caregiver (Δ^(S-T)) [Срок оценки: From baseline to the end of the slower flow feeding phase (approximately 4 days later)]

Критерии участия

Критерии включения

  • Mother-infant dyad: The biological mother is the legal guardian of the infant and has custody for ≥5 days per week (in cases of joint custody).
  • Maternal age: Mother is ≥18 years old.
  • Language: Mother understands spoken and written English sufficiently to provide informed consent, answer questionnaires and follow study instructions.
  • Gestational age: Infant was born at 37.0-42.0 weeks gestation.
  • Birthweight: Infant's birthweight was appropriate for gestational age.
  • Bottle feeding: Infant currently receives at least one bottle feeding of ≥2 ounces at least once per week.
  • Residence: Family lives within approximately one hours driving distance of Ann Arbor, Michigan to participate in an at- home appointment or is willing to drive to the U-M North Campus research site.
  • Infant age: Infant is 4.0-6.0 months old at enrollment.

Критерии исключения

  • Current maternal depression or anxiety, as assessed by screening questionnaires, or any cognitive impairment that would limit ability to follow study instructions.
  • Infant developmental delay, genetic condition, or medical problems or diagnosis affecting current or future eating, growth, or development.
  • History of significant sucking or feeding difficulties or breastfeeding difficulties requiring significant medical intervention or support.
  • Current weight-for-age below the 10th percentile or significant history of poor weight gain.
  • Infant already typically uses a slower-flow nipple (flow rate < 5 mL/min).

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
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT07665983 · HUM00278538 · 1K99HD112517-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗