Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
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: Human milk.
- Кому может быть актуально
- Состояния в реестре: Prematurity. Базовые параметры: 6 Hours — 4 Days · 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm
Обзор
The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation.
Подробное описание
Participants will be randomized once they reach 120 mL/kg/day. Clinicians will be able to increase feeds each day as they see fit, until the patient reaches the target goal of 140-160 mL/kg/day or 180-200 mL/kg/day. They will then maintain this volume until 34 weeks postmenstrual age. Researchers will compare these two targets to see if higher feeding volumes prevent faltering growth without causing adverse metabolic outcomes.
Participants will:
* Have a feeding volume of 180-200 mL/kg/day or a volume of 140-160 mL/kg/day until 34 weeks corrected age * Have four body composition assessments with a bioelectrical impedance analyzer throughout study period * Have four stool samples collected throughout study period * Have four maternal breastmilk samples collected and analyzed throughout the study period * Have one blood sample collected at 36 weeks corrected age * Have the option to participate in a follow-up survey completed by parents at 2-3 years of age
Вмешательства
- Пищевая добавка Human milk
maternal breastmilk or donor breastmilk
Первичные конечные точки
- Fat-free Mass (FFM)-For-age-Z-score [Срок оценки: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer]
Вторичные конечные точки (12)
- Body fat percentage [Срок оценки: Birth to 36 weeks postmenstrual age]
- Anthropometric Measurements [Срок оценки: Birth to 36 weeks postmenstrual age]
- Bronchopulmonary Dysplasia [Срок оценки: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer]
- Number of Days Alive and Receiving Full Enteral Feeding [Срок оценки: Birth to 28 days]
- Duration of Hospital Stay in Days [Срок оценки: Birth to 120 days or discharge, whichever occurs first]
- Growth Rate [Срок оценки: Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first).]
- Number of Participants with Postnatal Faltering Growth [Срок оценки: 36 weeks or hospital discharge (whichever occurs first)]
- Number of Participants diagnosed with Necrotizing Enterocolitis [Срок оценки: From birth up to 120 days following birth]
- Number of Participants with Diagnosis of Intestinal Perforation [Срок оценки: From birth up to 120 days following birth]
- Death [Срок оценки: Birth to 120 days]
- Culture-proven Sepsis [Срок оценки: Birth to 120 days]
- Fat Mass (FM)- For age Z-score [Срок оценки: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer]
Критерии участия
Критерии включения
- Gestational age between 27 0/7 and 31 6/7 weeks
- Birthweight of 1500 grams or less
- Human milk feeding during the first 14 days after birth
- Full enteral feeding (120mL/kg/day or more) within the first 14 days after birth
Критерии исключения
- Necrotizing enterocolitis stage 2 or greater
- Spontaneous intestinal perforation
- Major congenital/chromosomal anomalies
- Terminal illness requiring limited or withheld support
- Intention to restrict fluid intake after the first 14 postnatal days due to the presence of a symptomatic patent ductus arteriosus (PDA)
- Any formula feeding within the first 14 days after birth
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
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 4 центра
- University of Alabama at Birmingham — Birmingham
- University of Mississippi Medical Center — Jackson
- University of Texas Southwestern Medical Center at Dallas — Dallas
- University of Texas Health Science Center at Houston — Houston
Идентификаторы
NCT: NCT06420531 · IRB-300013026 · R01HD117932