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NCT Number: NCT07364500

Protocol-driven Nutrition in Preterm Infants

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.

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Key information

Conditions

Preterm Infants

Age range

22 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brno University Hospital, Brno, Czech Republic, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutrition plan supported by advanced clinical nutrition software

Dietary Supplement

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.

Primary outcomes

  1. Z-score for body weight at 36 weeks corrected gestational age

    Time frame: Up to a corrected gestational age of 36 weeks

  2. Z-score for body length at 36 weeks corrected gestational age

    Time frame: Up to a corrected gestational age of 36 weeks

  3. Z-score for head circumference at 36 weeks corrected gestational age

    Time frame: Up to a corrected gestational age of 36 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Dokoupilová, MSc

CONTACT

[email protected]

+420725441408

Lucie Mandelová, Ph.D.

CONTACT

[email protected]

+420770190828

Sponsors and collaborators

Lead sponsor

Institute of Health Information and Statistics of the Czech Republic

Other Gov

Collaborators

  • Brno University Hospital
  • General University Hospital, Prague
  • Tomáš Baťa Regional Hospital in Zlín
  • University Hospital Olomouc
  • České Budějovice Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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