Preterm Infants
Conditions
Keywords
preterm infants, nutrition of preterm infants, human milk analysis, nutrition monitoring, Czech Republic
Brief summary
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_SUPPLEMENTNutrition 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 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.
Sponsors
Institute of Health Information and Statistics of the Czech Republic
General University Hospital, Prague
University Hospital Olomouc
České Budějovice Hospital
Tomáš Baťa Regional Hospital in Zlín
Brno University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Weeks to 32 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Countries
Czechia
Contacts
CONTACTDaniela Dokoupilová, MSc
CONTACTLucie Mandelová, Ph.D.
STUDY_DIRECTORRichard Plavka, prof.
General Hospital University in Prague
STUDY_CHAIRJiří Dušek, M.D., MHA
České Budějovice Hospital
Outcome results
None listed