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Clinical Trial NCT07364500 for Preterm Infants is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Protocol-driven Nutrition in Preterm Infants 400

Recruiting
Clinical Trial NCT07364500 is an interventional study for Preterm Infants that is recruiting. It started on 21 August 2025 with plans to enroll 400 participants. Led by Institute of Health Information and Statistics of the Czech Republic, it is expected to complete by 1 February 2027. The latest data from ClinicalTrials.gov was last updated on 23 January 2026.
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 over...

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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 nutrit...

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Official Title

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

Conditions
Preterm Infants
Other Study IDs
  • UZIS 2025/2
NCT ID Number
NCT07364500
Start Date (Actual)
2025-08-21
Last Update Posted
2026-01-23
Completion Date (Estimated)
2027-02
Enrollment (Estimated)
400
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
preterm infants
nutrition of preterm infants
human milk analysis
nutrition monitoring
Czech Republic
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherPreterm 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.
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...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
22 Weeks
Eligible Sexes
All
  • 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.

  • 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.
Institute of Health Information and Statistics of the Czech Republic logoInstitute of Health Information and Statistics of the Czech Republic
Study Central Contact
Contact: Daniela Dokoupilová, MSc, +420725441408, [email protected]
Contact: Lucie Mandelová, Ph.D., +420770190828, [email protected]
5 Study Locations in 1 Countries

Czech Republic

Brno University Hospital, Brno, Czech Republic, Czechia
Kateřina Fojtíková, MD, Contact, [email protected]
Not yet recruiting
České Budějovice Hospital, České Budějovice, Czech Republic, Czechia
Jiří Dušek, MD, Contact, [email protected]
Recruiting
University Hospital Olomouc, Olomouc, Czech Republic, Czechia
Martin Wita, MD, Contact, [email protected]
Recruiting
General University Hospital, Prague, Czech Republic, Czechia
Blanka Zlatohlavková, MD, Contact, [email protected]
Recruiting
Tomáš Baťa Regional Hospital in Zlín, Zlín, Czechia
Marcela Pekařová, MD, Contact, [email protected]
Recruiting