Early Detection and Prevention of Health Complications in Premature Infants - Protocol-driven Nutrition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 5
- 主要终点
- Z-score for body weight at 36 weeks corrected gestational age
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 22 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Preterm infants
The nutritional management of enrolled patients will be guided by individualized plans developed by attending physicians, supported by advanced clinical nutrition software enabling precise monitoring and adjustment based on ongoing anthropometric and dietary data.
干预措施: Nutrition plan supported by advanced clinical nutrition software (Dietary Supplement)
结局指标
主要结局
Z-score for body weight at 36 weeks corrected gestational age
时间窗: Up to a corrected gestational age of 36 weeks
Z-score for body length at 36 weeks corrected gestational age
时间窗: Up to a corrected gestational age of 36 weeks
Z-score for head circumference at 36 weeks corrected gestational age
时间窗: Up to a corrected gestational age of 36 weeks
次要结局
未报告次要终点