NCT07364500

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Aug 2025

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Aug 2025Feb 2027

Study Start

First participant enrolled

August 21, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 13, 2026

Last Update Submit

January 21, 2026

Conditions

Preterm Infants

Keywords

preterm infantsnutrition of preterm infantshuman milk analysisnutrition monitoringCzech Republic

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

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.

Dietary Supplement: Nutrition plan supported by advanced clinical nutrition software

Interventions

Nutrition plan supported by advanced clinical nutrition softwareDIETARY_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.

Preterm infants

Eligibility Criteria

Age22 Weeks - 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Brno University Hospital

Brno, Czech Republic, Czechia

NOT YET RECRUITING

České Budějovice Hospital

České Budějovice, Czech Republic, Czechia

RECRUITING

University Hospital Olomouc

Olomouc, Czech Republic, Czechia

RECRUITING

General University Hospital

Prague, Czech Republic, Czechia

RECRUITING

Tomáš Baťa Regional Hospital in Zlín

Zlín, Czechia

RECRUITING

Study Officials

  • Richard Plavka, prof.

    General Hospital University in Prague

    STUDY DIRECTOR

  • Jiří Dušek, M.D., MHA

    České Budějovice Hospital

    STUDY CHAIR

Central Study Contacts

Daniela Dokoupilová, MSc

CONTACT

+420725441408daniela.dokoupilova@uzis.cz

Lucie Mandelová, Ph.D.

CONTACT

+420770190828lucie.mandelova@uzis.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 23, 2026

Study Start

August 21, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

CZ(5)