Protocol-driven Nutrition in Preterm Infants

Официальное название

Early Detection and Prevention of Health Complications in Premature Infants - Protocol-driven Nutrition

Обзор

The project is a national, prospective, multicenter, interventional pilot project focused on protocol-driven nutrition in preterm infants in the Czech republic. The primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of preterm newborns in the field of nutrition. This will reduce health risks in premature infants and minimize the negative impacts on the overall development of the child and the family of the premature infant.

Подробное описание

The project is a national, prospective, multicenter, interventional pilot project focused on protocol-driven nutrition in preterm infants in the Czech republic.

The main goal of the project is standardization of nutrition of premature newborns across healthcare facilities with the aim to optimize postnatal growth and reduce complications associated with prematurity through individualized and closely monitored nutritional plans.

The project will be running in 5 perinatology centers in the Czech Republic. It is expected that 400 premature infants will participate. The project is supported by the European Social Fund (Operational Program Employment Plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22\_005/0002020. The study has been reviewed and approved by multiple local ethical committees. The listed IRB represents the lead national ethical committee overseeing the trial.

Вмешательства

• Пищевая добавка Nutrition plan supported by advanced clinical nutrition software
  Infants undergo regular anthropometric assessments (weight, length, head circumference), and detailed fluid and nutrient intake is recorded. Weekly analysis of the macronutrient composition of maternal or donor milk is conducted, enabling personalized fortification to meet the infant's current needs. The intervention utilizes a dedicated nutrition software tool, incorporating Fenton growth charts, to support clinical decisions and track progress via z-scores compared to term-born infants. By al

Первичные конечные точки

• Z-score for body weight at 36 weeks corrected gestational age [Срок оценки: Up to a corrected gestational age of 36 weeks]
• Z-score for body length at 36 weeks corrected gestational age [Срок оценки: Up to a corrected gestational age of 36 weeks]
• Z-score for head circumference at 36 weeks corrected gestational age [Срок оценки: Up to a corrected gestational age of 36 weeks]

Критерии участия

Критерии включения

• Infants born before 31+6 weeks gestation.
• Signed consent for participation in the project and consent for the processing of personal data.
• Admission to neonatal care in the participating hospital within 24 hours after birth.

Критерии исключения

• Congenital malformations.
• Fetal hydrops.
• Intraventricular hemorrhage requiring drainage.
• Necrotizing enterocolitis requiring surgical treatment.
• Surgically treated hydrocephalus.
• Unsigned consent for participation in the project and/or consent for the processing of personal data.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Чехия · 5 центров

• Brno University Hospital — Brno
• České Budějovice Hospital — České Budějovice
• University Hospital Olomouc — Olomouc
• General University Hospital — Prague
• Tomáš Baťa Regional Hospital in Zlín — Zlín

Идентификаторы

NCT: NCT07364500 · UZIS 2025/2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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