Идёт набор NCT06212427

Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)

Без фазы С лечением Premature Infant Low Birthweight Infant

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: HMO supplement.
Кому может быть актуально: Состояния в реестре: Premature Infant, Low Birthweight Infant. Базовые параметры: 0 Days — 14 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: Австрия, Германия
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

Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs): A Post-Market Study

Обзор

The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose \[2'FL\] and lacto-N-neotetraose \[LNnT\], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting. A comparison with data collected retrospectively from a historical group at each site will be made for time to reach full enteral feeding, growth and adverse events. Infants in the historical group were not exposed to an HMO supplement but followed the same local nutrition protocol to avoid confounding by differences in clinical or feeding practice.

Вмешательства

Пищевая добавка HMO supplement
Liquid supplement containing 2 specific HMOs. Supplement will be given 3-4 times a day, not mixed with any feeding.

Первичные конечные точки

Feeding tolerance [Срок оценки: From birth until achievement of full enteral feeding (1 to 3 weeks)]
Feeding tolerance [Срок оценки: From birth until achievement of full enteral feeding (1 to 3 weeks)]

Вторичные конечные точки (5)

Gastrointestinal tolerance [Срок оценки: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks]
Weight gain [Срок оценки: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks]
Length gain [Срок оценки: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks]
Head circumference gain [Срок оценки: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks]
Safety via reporting of adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks]

Критерии участия

Критерии включения

Written informed consent has been obtained from at least one parent (or other legally acceptable representative \[LAR\], if applicable)
Infant's parent(s)/LAR is of legal age of majority, has parental authority, must understand the consent form and other relevant study documents, and is willing and able to fulfil the requirements of the study protocol
Infant gestational age is ≤ 34 weeks as determined by the first day of the mother's last menstrual period or by fetal ultrasound
Infant birth weight ≤ 2500g
Infant postnatal age ≤ 14 days
Infant has tolerated trophic feeds (e.g., 10-15 mL/kg/day) for at least 24 hours but has not yet reached full enteral feeding

Критерии исключения

Infant is clinically unstable, for example:

Infant has hemodynamic instability as evidenced by clinical signs of sepsis, hypotension (MAP < 5th percentile for age for at least three hours), or is receiving vasopressor drugs
Infant has received an exchange transfusion within the past 48 hours
Infant has had an episode of severe asphyxia at birth (PH less than 7.0)
Infant has signs of necrotizing enterocolitis according to modified Bell staging criteria (stage IIA or higher)
Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)
Infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
Participation in another interventional clinical study that may interfere with the results of this study

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

Здоровые добровольцы: Нет