Actively Recruiting

Phase Not Applicable
Age: 22Weeks - 32Weeks
All Genders
ID07364500

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

Led by Institute of Health Information and Statistics of the Czech Republic · Updated on 2026-01-23

400

Participants Needed

5

Research Sites

9 weeks

Total Duration

On this page

Sponsors

I

Institute of Health Information and Statistics of the Czech Republic

Lead Sponsor

G

General University Hospital, Prague

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to develop and test a standardized, protocol-driven nutritional approach for preterm infants in the Czech Republic. The goal is to improve early growth and reduce health complications related to prematurity by creating a national care methodology focused on individualized nutrition. This multicenter pilot project involves multiple healthcare facilities and is supported by national and European funding. The study involves personalized nutrition plans created by attending physicians using advanced clinical nutrition software. This software helps monitor infants' growth and nutrient intake precisely, adjusting plans based on regular weight, length, and head circumference measurements and weekly analysis of maternal or donor milk composition. The project promotes early enteral feeding to improve growth and reduce risks like bronchopulmonary dysplasia and retinopathy. Participants will be preterm infants admitted to neonatal care within 24 hours of birth and monitored until 36 weeks corrected gestational age. Researchers will track growth using z-scores for body weight, length, and head circumference compared to typical term infants. The study includes detailed data collection on nutrition and growth, with close clinical monitoring to assess safety and outcomes over the study period.

CONDITIONS

Brief Title

Protocol-driven Nutrition in Preterm Infants

Who Can Participate

Age: 22Weeks - 32Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants born before 31+6 weeks gestation
  • Signed consent for participation and data processing
  • Admission to neonatal care in participating hospital within 24 hours after birth
Not Eligible

You will not qualify if you...

  • Presence of congenital malformations
  • Fetal hydrops
  • Intraventricular hemorrhage requiring drainage
  • Necrotizing enterocolitis requiring surgical treatment
  • Surgically treated hydrocephalus
  • No signed consent for participation or data processing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 24 hours after birth

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 36 weeks corrected gestational age

Participants receive individualized nutritional management guided by advanced clinical nutrition software, with regular anthropometric assessments and weekly analysis of milk composition to optimize growth and reduce complications.

Regular assessments integrated within neonatal care

Trial Site Locations

Total: 5 locations

1

Brno University Hospital

Brno, Czech Republic, Czechia

Not Yet Recruiting

2

České Budějovice Hospital

České Budějovice, Czech Republic, Czechia

Actively Recruiting

3

University Hospital Olomouc

Olomouc, Czech Republic, Czechia

Actively Recruiting

4

General University Hospital

Prague, Czech Republic, Czechia

Actively Recruiting

5

Tomáš Baťa Regional Hospital in Zlín

Zlín, Czechia

Actively Recruiting

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Research Team

D

Daniela Dokoupilová, MSc

L

Lucie Mandelová, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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Frequently Asked Questions

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