Protocol-driven Nutrition in Preterm Infants

Institute of Health Information and Statistics of the Czech Republic

Status: Enrolling

Conditions: Preterm Infants

Treatments: Dietary Supplement: Nutrition plan supported by advanced clinical nutrition software

Study type: Interventional

Funder types: Other

Identifiers

NCT07364500

UZIS 2025/2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 22 to 32 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Preterm infants

Other group

Description:

The nutritional management of enrolled patients will be guided by individualized plans developed by attending physicians, supported by advanced clinical nutrition software enabling precise monitoring and adjustment based on ongoing anthropometric and dietary data.

Treatment:

Dietary Supplement: Nutrition plan supported by advanced clinical nutrition software