RecruitingNot ApplicableNCT07364500

Protocol-driven Nutrition in Preterm Infants

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


Sponsor

Institute of Health Information and Statistics of the Czech Republic

Enrollment

400 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 22 WeeksMax Age: 32 Weeks

Inclusion Criteria3

  • 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 Criteria6

  • 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.

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Interventions

DIETARY_SUPPLEMENTNutrition 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.


Locations(5)

Brno University Hospital

Brno, Czech Republic, Czechia

České Budějovice Hospital

České Budějovice, Czech Republic, Czechia

University Hospital Olomouc

Olomouc, Czech Republic, Czechia

General University Hospital

Prague, Czech Republic, Czechia

Tomáš Baťa Regional Hospital in Zlín

Zlín, Czechia

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NCT07364500