Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC) (NCT04413994) | Clinical Trial Compass
RecruitingNot Applicable
Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)
Austria200 participantsStarted 2020-10-09
Plain-language summary
Early vascular aging has its origins in fetal and neonatal life. The NEOVASC clinical trial aims to determine the effects of an exclusive human milk diet in extremely preterm infants on long-term cardiovascular health.
Who can participate
Age range
1 Day – 5 Years
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
. Extremely preterm infants with a birth weight of 500-1250g.
. Feeding is NPO or exclusive human milk prior to enrollment.
. Parent(s) willing to sign informed consent.-
Exclusion criteria
. Infants with a birth weight \<500g or \>1250g
. Subjects diagnosed with inborn errors of metabolism such as galactosemia, phenylketonuria
. Subjects who have not been NPO or fed exclusive human milk diet prior to enrollment.
. Presence of major congenital malformation.
. Presence of intestinal perforation or Stage 2 Necrotizing enterocolitis prior to enrollment.
. Parent(s) not willing to sign informed consent.
. Unable to participate for any reason based on the decision of the study investigator (e.g. unlikely to survive the study period).
. Term-born children with an adequate birth weight
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
Fasting blood glucose
Timeframe: "First day of life" up to "five years of life"