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

NCT04413994 | Recruiting DMC

• 2 other identifiers: NEOVASC868624
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prematurity; Vascular Aging

Outcome Measures

Primary Outcomes (3)

• Fasting blood glucose

  Primary outcome is the difference in fasting blood glucose at five years of age

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

• Blood pressure

  Primary outcome is the difference in blood pressure at five years of age

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

• Distensibility of aorta

  Primary outcome is the difference in the distensibility of the descending aorta using validated echocardiographic protocols at five years of age

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

Secondary Outcomes (5)

• Fasting blood glucose

  "First day of life" up to "24 months"

• Blood pressure

  "First day of life" up to "24 months"

• BMI

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

• Insulin sensitivity

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

• Lipid profile

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

Other Outcomes (6)

• Fasting blood glucose

  "five years of age"

• Blood pressure

  "five years of age"

• Distensibility of the descending aorta

  "five years of age"

Study Arms (3)

Randomized study product group

ACTIVE COMPARATOR

receiving study product (human milk fortifier "Humavant") until a gestational age of 36 weeks

Dietary Supplement: Humavant

Randomized control group

ACTIVE COMPARATOR

receiving study product until a gestational age of 32 weeks and reference product (bovine based fortifier or bovine formula) after 32 weeks of gestation

Dietary Supplement: Humavant

Term control group

NO INTERVENTION

Term-born controls as a reference group for outcome parameters

Interventions

Humavant DIETARY_SUPPLEMENT

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.

Randomized control group; Randomized study product group

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Prolacta Bioscience: lead
• Medical University of Vienna: collaborator
• Federal University Teaching Hospital, Feldkirch, Austria: collaborator
• Paracelsus Medical University: collaborator

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Tyrol, A-6020, Austria

RECRUITING

Related Publications (1)

• Mitterer W, Binder C, Blassnig-Ezeh A, Auer-Hackenberg L, Berger A, Simma B, Wald M, Lee M, Kiechl-Kohlendorfer U. Effects of an exclusive human-milk diet in preterm neonates on early vascular aging risk factors (NEOVASC): study protocol for a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial. Trials. 2021 Jul 31;22(1):509. doi: 10.1186/s13063-021-05445-9.

  PMID: 34332629 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ursula Kiechl-Kohlendorfer, MD, MSc

  Medical University of Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ursula Kiechl-Kohlendorfer, MD, MSc

CONTACT

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

Wolfgang Mitterer, MD

CONTACT

+43 670 2021490; wolfgang.mitterer@student.i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The NEO-VASC study is a multicentric, prospective, randomized, controlled, open and parallel group clinical trial.

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 4, 2020
• Study Start: October 9, 2020
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)