NCT07364500

Protocol-driven Nutrition in Preterm Infants

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Institute of Health Information and Statistics of the Czech Republic · Other Government
• Sex: All
• Age: 22 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

The project is a national, prospective, multicenter, interventional pilot project focused on protocol-driven nutrition in preterm infants in the Czech republic. The main goal of the project is standardization of nutrition of premature newborns across healthcare facilities with the aim to optimize postnatal growth and reduce complications associated with prematurity through individualized and closely monitored nutritional plans. The project will be running in 5 perinatology centers in the Czech Republic. It is expected that 400 premature infants will participate. The project is supported by the European Social Fund (Operational Program Employment Plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22\_005/0002020. The study has been reviewed and approved by multiple local ethical committees. The listed IRB represents the lead national ethical committee overseeing the trial.

Conditions

• Preterm Infants

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutrition 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.

Timeline

• Start date: 2025-08-21
• Primary completion: 2026-11-30
• Completion: 2027-02-01
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

5 sites across 1 country: Czechia