Protocol-driven Nutrition in Preterm Infants (NCT07364500) | Clinical Trial Compass
RecruitingNot Applicable
Protocol-driven Nutrition in Preterm Infants
Czechia400 participantsStarted 2025-08-21
Plain-language 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.
Who can participate
Age range
22 Weeks – 32 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Z-score for body weight at 36 weeks corrected gestational age
Timeframe: Up to a corrected gestational age of 36 weeks
2
Z-score for body length at 36 weeks corrected gestational age
Timeframe: Up to a corrected gestational age of 36 weeks
3
Z-score for head circumference at 36 weeks corrected gestational age
Timeframe: Up to a corrected gestational age of 36 weeks
Trial details
NCT IDNCT07364500
SponsorInstitute of Health Information and Statistics of the Czech Republic