Protocol-driven Nutrition in Preterm Infants

January 21, 2026 updated by: Institute of Health Information and Statistics of the Czech Republic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Zlín, Czechia
    • Czech Republic
      • Brno, Czech Republic, Czechia
      • Olomouc, Czech Republic, Czechia
      • Prague, Czech Republic, Czechia
      • České Budějovice, Czech Republic, Czechia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Z-score for body weight at 36 weeks corrected gestational age
Time Frame: Up to a corrected gestational age of 36 weeks
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
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
Up to a corrected gestational age of 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Health Information and Statistics of the Czech Republic

Collaborators

Brno University Hospital
University Hospital Olomouc
Tomáš Baťa Regional Hospital in Zlín
General University Hospital, Prague
České Budějovice Hospital

Investigators

  • Study Director: Richard Plavka, prof., General Hospital University in Prague
  • Study Chair: Jiří Dušek, M.D., MHA, Ceske Budejovice Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UZIS 2025/2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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