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| Name | Class |
|---|---|
| General University Hospital, Prague | OTHER |
| University Hospital Olomouc | OTHER |
| České Budějovice Hospital | OTHER |
| Tomáš Baťa Regional Hospital in Zlín |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm infants | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition plan supported by advanced clinical nutrition software | Dietary Supplement | 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 aligning nutrient supply with individual requirements and promoting early enteral feeding, the project seeks to enhance growth outcomes, minimize risks such as bronchopulmonary dysplasia or retinopathy, and shorten the length of stay in neonatal intensive care. |
| Measure | Description | Time Frame |
|---|---|---|
| Z-score for body weight at 36 weeks corrected gestational age | Up to a corrected gestational age of 36 weeks | |
| Z-score for body length at 36 weeks corrected gestational age | Up to a corrected gestational age of 36 weeks | |
| Z-score for head circumference at 36 weeks corrected gestational age | Up to a corrected gestational age of 36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Dokoupilová, MSc | Contact | +420725441408 | daniela.dokoupilova@uzis.cz | |
| Lucie Mandelová, Ph.D. | Contact | +420770190828 | lucie.mandelova@uzis.cz |
| Name | Affiliation | Role |
|---|---|---|
| Richard Plavka, prof. | General Hospital University in Prague | Study Director |
| Jiří Dušek, M.D., MHA | České Budějovice Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno University Hospital | Not yet recruiting | Brno | Czech Republic | Czechia |
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| UNKNOWN |
| Brno University Hospital | OTHER |
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| České Budějovice Hospital | Recruiting | České Budějovice | Czech Republic | Czechia |
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| University Hospital Olomouc | Recruiting | Olomouc | Czech Republic | Czechia |
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| General University Hospital | Recruiting | Prague | Czech Republic | Czechia |
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| Tomáš Baťa Regional Hospital in Zlín | Recruiting | Zlín | Czechia |
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