Actively Recruiting

Phase Not Applicable
Age: 1Day - 5Years
All Genders
NCT04413994

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

Led by Prolacta Bioscience · Updated on 2025-08-29

200

Participants Needed

1

Research Sites

398 weeks

Total Duration

On this page

Sponsors

P

Prolacta Bioscience

Lead Sponsor

M

Medical University of Vienna

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Day - 5Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Term-born children with an adequate birth weight
  • Parent(s) willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Infants with a birth weight less than 500g or more than 1250g
  • Diagnosed with inborn errors of metabolism such as galactosemia or phenylketonuria
  • Not 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 investigator's decision (e.g., unlikely to survive study period)
  • Subjects with acute or chronic illness in the term-born group

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of Innsbruck

Innsbruck, Tyrol, Austria, A-6020

Actively Recruiting

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Research Team

U

Ursula Kiechl-Kohlendorfer, MD, MSc

CONTACT

W

Wolfgang Mitterer, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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