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 range1 Day – 5 Years

SexALL

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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

What they're measuring

Fasting blood glucose

Timeframe: "First day of life" up to "five years of life"

Blood pressure

Timeframe: "First day of life" up to "five years"

Distensibility of aorta

Timeframe: "First day of life" up to "five years"

Trial details

NCT IDNCT04413994

SponsorProlacta Bioscience

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06-01

Contact for this trial

Ursula Kiechl-Kohlendorfer, MD, MSc

+43 512 504 27309 ursula.kohlendorfer@i-med.ac.at

View on ClinicalTrials.gov More Prematurity trials