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RECRUITING
NCT04413994
NA

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

Sponsor: Prolacta Bioscience

View on ClinicalTrials.gov

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.

Official title: Effects of an Exclusive Human-milk Diet in Preterm NEOnates on Early VASCular Aging Risk Factors (NEOVASC)

Key Details

Gender

All

Age Range

1 Day - 5 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2020-10-09

Completion Date

2028-06-01

Last Updated

2025-08-29

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Humavant

Premature infants are randomized to either: 1. An exclusive human milk diet which contains mother's milk or pasteurized donor human milk and the human milk fortifier until 36 weeks of gestation; OR 2. Human milk (as long as available) and the human milk fortifier (as long as human milk is available) until a maximum of 32 weeks of gestation and thereafter human milk with a bovine-based fortifier or preterm formula. After 36 weeks of gestation, human milk with a bovine-based fortifier or preterm formula is used in both groups. As a control group, term-born age-matched controls are included.

Locations (1)

Medical University of Innsbruck

Innsbruck, Tyrol, Austria