Protocol-driven Nutrition in Preterm Infants
ConditionPreterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-32
SponsorInstitute of Health Information and Statistics of the Czech Republic
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Congenital malformations.
Fetal hydrops.
Intraventricular hemorrhage requiring drainage.
Necrotizing enterocolitis requiring surgical treatment.
Trial design
Design model
Single group
Treatments tested in this trial
Nutrition plan supported by advanced clinical nutrition software
Dietary supplementInfants 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.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Preterm infantsOther 1 intervention
Trial outcomes
Primary outcomes
1
Z-score for body weight at 36 weeks corrected gestational age
Time frame
Up to a corrected gestational age of 36 weeks2
Z-score for body length at 36 weeks corrected gestational age
Time frame
Up to a corrected gestational age of 36 weeks3
Z-score for head circumference at 36 weeks corrected gestational age
Time frame
Up to a corrected gestational age of 36 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Health Information and Statistics of the Czech Republic
Lead sponsor
General University Hospital, Prague
Collaborator
University Hospital Olomouc
Collaborator
České Budějovice Hospital
Collaborator
Tomáš Baťa Regional Hospital in Zlín
Collaborator
Brno University Hospital
Collaborator
Source ClinicalTrials.gov