Protocol-driven Nutrition in Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nutrition plan supported by advanced clinical nutrition software.
- Who it may be relevant to
- Registry conditions: Preterm Infants. Basic parameters: 22 Weeks — 32 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Detection and Prevention of Health Complications in Premature Infants - Protocol-driven Nutrition
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement 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
Primary outcome measures
- Z-score for body weight at 36 weeks corrected gestational age [Time frame: Up to a corrected gestational age of 36 weeks]
- Z-score for body length at 36 weeks corrected gestational age [Time frame: Up to a corrected gestational age of 36 weeks]
- Z-score for head circumference at 36 weeks corrected gestational age [Time frame: Up to a corrected gestational age of 36 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Czechia · 5 centers
- Brno University Hospital — Brno
- České Budějovice Hospital — České Budějovice
- University Hospital Olomouc — Olomouc
- General University Hospital — Prague
- Tomáš Baťa Regional Hospital in Zlín — Zlín
Identifiers
NCT: NCT07364500 · UZIS 2025/2