Clinical trial Recruiting at 4 sites Interventional Ages 22 Weeks to 32 Weeks

Standardized nutrition for very preterm infants

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

Run by Institute of Health Information and Statistics of the Czech Republic · NCT07364500 · Data updated 2026-11-12

This project will try a standardized, software-supported nutrition plan for babies born before 32 weeks to help them grow better and reduce complications.

Quick facts

Study typeInterventional
Ages22 Weeks to 32 Weeks
SexAll
Enrollment400 (estimated)
SponsorInstitute of Health Information and Statistics of the Czech Republic
Government
Locations5 sites (Brno, Czech Republic and 4 other locations)
StatusRecruiting
StartedAugust 21, 2025
Main results expectedMarch 2027
Study endsAugust 2027
Registry record updatedNovember 3, 2026
Trial IDNCT07364500 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Infants born before 31+6 weeks gestation who are admitted to a participating neonatal unit within 24 hours of birth and whose parents provide informed consent.

Probably not a fit

Infants with major congenital malformations, fetal hydrops, intraventricular hemorrhage requiring drainage, necrotizing enterocolitis requiring surgery, or surgically treated hydrocephalus are excluded and unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a national, prospective, multicenter interventional pilot project in the Czech Republic testing protocol-driven nutrition for preterm infants. The goal is to prepare, test, and develop a national methodology to standardize nutrition across neonatal units, optimizing postnatal growth and reducing complications of prematurity through individualized, closely monitored plans. About 400 infants born before 31+6 weeks will be enrolled across five perinatology centers and managed using advanced clinical nutrition software and human milk analysis to guide feeding. The project is supported by the European Social Fund and the Czech state, has ethics approvals, and is registered with the national authorities.

Why it matters

Potential benefit: If successful, the program could improve growth and reduce nutrition-related complications in very preterm infants while establishing a national standard of care.

How similar studies have gone: Previous single-center and small multicenter studies of individualized nutrition and human milk analysis have reported improved nutrient delivery and growth, but large-scale, national protocol-driven programs remain less tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • 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
  • Brno University Hospital
    Brno, Czech Republic, Czechia
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.