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Идёт набор NCT07216664

Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants

Без фазы С лечением Infant, Premature, Diseases

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: Multisensory early oral administration of human milk.
Кому может быть актуально
Состояния в реестре: Infant, Premature, Diseases. Базовые параметры: 23 Weeks — 32 Weeks · 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

Randomized Controlled Trial of Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants: Enhancing Stress Regulation, Neurodevelopment, and Oral Feeding Skills

Обзор

The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants). The main question that this clinical trial aims to answer is: Does M-MILK improve stress regulation, support optimal neurodevelopment, and promote competent oral feeding skills in very preterm infants? Researchers will compare M-MILK to the standard of care to see if M-MILK helps very preterm infants. Specifically, researchers will compare the differences in: * Cortisol levels * DNA methylation of the two stress related genes (NR3C1 and HSD11B2) * Neurodevelopment * Oral feeding skills Participants in the M-MILK group will receive standard of care plus M-MILK intervention, which starts on day 3 of life and continues until they begin their oral feeding. M-MILK will be provided by clinical research nurses, during the day shift, up to 4 times a day. Participants in the standard of care group will continue to receive their usual care.

Вмешательства

  • Другое Multisensory early oral administration of human milk
    M-MILK is implemented starting on day 3 of life, during the day shift, after every hands-on care, during the beginning of a full gavage feeding, and up to 4 times a day. Infants receive M-MILK in small droplets via a 1-ml syringe. M-MILK will cease upon oral feeding initiation. Infants will receive either mother's own milk or donor's milk based on availability. Infants may receive up to 1 mL of milk each time based on their cues and responses. The 1 mL volume intake is included as part of their

Первичные конечные точки

  • Oral feeding Skills: EFS assessment total score at PO Initiation [Срок оценки: Up to 12 weeks after birth.]
  • Oral Feeding Skills: EFS assessment total score at 36 Weeks PMA [Срок оценки: 36 weeks postmenstrual age.]
Вторичные конечные точки (12)
  • Stress Regulation: Salivary Cortisol at PO Initiation [Срок оценки: Up to 12 weeks after birth.]
  • Stress Regulation: Salivary Cortisol at 36 Weeks PMA [Срок оценки: At 36 weeks postmenstrual age.]
  • Stress Regulation: Buccal Cell DNAm of NR3C1 Exon 1F Promoter at PO Initiation [Срок оценки: Up to 12 weeks after birth.]
  • Stress Regulation: Buccal Cell DNAm of NR3C1 Exon 1F Promoter at 36 Weeks PMA [Срок оценки: At 36 weeks postmenstrual age.]
  • Stress Regulation: Buccal Cell DNAm of HSD11B2 Promoter at PO Initiation [Срок оценки: Up to 12 weeks after birth.]
  • Stress Regulation: Buccal Cell DNAm of HSD11B2 Promoter at 36 Weeks PMA [Срок оценки: At 36 weeks postmenstrual age.]
  • Neurodevelopment: NNNS-II Attention score 36 Weeks PMA [Срок оценки: At 36 weeks postmenstrual age.]
  • Neurodevelopment: NNNS-II Handling score 36 Weeks PMA [Срок оценки: At 36 weeks postmenstrual age.]
  • Neurodevelopment: NNNS-II Self-Regulation 36 Weeks PMA [Срок оценки: At 36 weeks postmenstrual age.]
  • Neurodevelopment: NNNS-II Habituation score 36 Weeks PMA [Срок оценки: At 36 weeks postmenstrual age.]
  • Neurodevelopment: NNNS-II Arousal score 36 Weeks PMA [Срок оценки: At 36 weeks postmenstrual age.]
  • Neurodevelopment: NNNS-II Excitability score 36 Weeks PMA [Срок оценки: At 36 weeks postmenstrual age.]

Критерии участия

Критерии включения

  • Born at ≤ 32 weeks gestational age.
  • Receiving mother's own milk and/or donor human milk at the time of screening.

Критерии исключения

  • Receiving only formula.
  • Gastrointestinal defects, i.e., cleft lip or cleft palate.
  • Congenital cardiac defects requiring surgery.
  • Necrotizing enterocolitis.
  • Chromosomal abnormalities.

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
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 2 центра
  • Loyola University Chicago — Maywood
  • Loyola University Medical Center — Maywood

Публикации

  • Griffith T, Janusek L, White-Traut R, Green SJ, Sachin A, Joyce C. Study Protocol for a Randomized Controlled Trial of Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants: Enhancing Stress Regulation, Neurodevelopment, and Oral Feeding Skills. Biol Res Nurs. 2026 Jul;28(3):464-478. doi: 10.1177/10998004261418708. Epub 2026 Jan 19. PMID 41554032

Идентификаторы

NCT: NCT07216664 · 218601

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗