Standardized nutrition for very preterm infants
Early Detection and Prevention of Health Complications in Premature Infants - Protocol-driven Nutrition
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 22 Weeks to 32 Weeks |
| Sex | All |
| Sponsor | Institute of Health Information and Statistics of the Czech Republic Government |
| Locations | 5 sites (Brno, Czech Republic and 4 other locations) |
| Trial ID | NCT07364500 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Brno, Czech Republic and 4 other locations
- 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 contacts
- Study coordinator: Daniela Dokoupilová, MSc
- Email: daniela.dokoupilova@uzis.cz
- Phone: +420725441408
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.