Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)

Recruiting now · Not applicable

Conditions studied: Prematurity, Vascular Aging

In brief

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.

Key facts

Study ID

NCT04413994

Run by

Prolacta Bioscience

People needed

200

Starts

2020-10-09

Expected to finish

2028-06-01

Last updated by the study team

2025-08-29

Who can join

Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.-

You may not qualify if…

• 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 group:
• Inclusion criteria
• Term-born children with an adequate birth weight
• Parent(s) willing to sign informed consent
• Exclusion criteria
• Subjects with acute or chronic illness
• Parent(s) not willing to sign informed consent

Where it is running

• Medical University of Innsbruck — Innsbruck, Tyrol, Austria (enrolling)

Full record on ClinicalTrials.gov

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