PrematurityNEOVASCNCT04413994
Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)
A study testing Humavant in people with Prematurity and Vascular Aging, run by Prolacta Bioscience at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 5 years
- Conditions the study is for
- Prematurity, Vascular Aging
- What is being tested?
- Humavant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 9 Oct 2020to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- 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:
- Subjects with acute or chronic illness
- Parent(s) not willing to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Innsbruck
Innsbruck, Tyrol, A-6020
Ursula Kiechl-Kohlendorfer, MD, MSc, +43 512 504 27309, ursula.kohlendorfer@i-med.ac.at
Wolfgang Mitterer, MD, wolfgang.mitterer@student.i-med.ac.at
About this study
Official title: Effects of an Exclusive Human-milk Diet in Preterm NEOnates on Early VASCular Aging Risk Factors (NEOVASC)
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.
Read the detailed description
Early vascular aging has its origins in fetal and neonatal life. This early period of life plays an important role in the development of obesity, high blood pressure, abnormalities in lipid metabolism and non-insulin dependent diabetes. Increased cardiovascular risk in formerly preterm infants constitutes a health problem of steadily growing relevance. Emerging evidence suggests that human milk feeding has substantial benefits to the health of all infants, especially for those born prematurely. Unfortunately, human milk alone does not provide sufficient concentrations of nutrients, especially calcium, phosphorus, protein, and fat needed for these infants to grow satisfactorily. For that purpose, fortifiers are used to help increase the nutritional value of human milk.
The NEOVASC study is a multicentric, prospective, randomized, controlled, open and parallel group clinical trial. A total of 200 extremely preterm infants and 100 term infants are recruited for the test and control group, respectively. Infants in the test group (i.e., premature neonates) are randomized to either:
- An exclusive human milk diet which contains mother's milk or pasteurized donor human milk and a human milk fortifier until 36 weeks of gestation; OR
- Human milk (as long as available) and a 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. Participants within this control group are not enrolled at the time of birth but instead recruited in various kindergartens at the age of five. Therefore, data from birth is taken from the mother-child-booklet, which contains clinical records about the pregnancy, birth and early life of children born in Austria. The total study duration is scheduled for 96 months with a recruitment phase of 36 months. Follow-up visits are planned at one, two and five years of age for the test group.
The purpose of the NEOVASC clinical trial is to characterize early life stressors by assessing the effects of a physiological (i.e., human milk-based) nutrition in extremely preterm infants during the vulnerable preterm period on the risk of metabolic and vascular complications in later life. Outcomes include predictors and intermediate components of cardiovascular disease.
- Conditions
- Prematurity, Vascular Aging
- Being tested
- Humavant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HumavantDietary supplement
Premature infants are randomized to either:
- 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
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Randomized study product group | Active comparator | receiving study product (human milk fortifier "Humavant") until a gestational age of 36 weeks Receives: 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 Receives: Dietary Supplement: Humavant |
| Term control group | No intervention | Term-born controls as a reference group for outcome parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose
Primary outcome is the difference in fasting blood glucose at five years of age
Measured: "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
Measured: "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
Measured: "First day of life" up to "five years"
Secondary outcomes (5)
Fasting blood glucose
Secondary outcome is fasting glucose at a corrected age of one and two years.
Measured: "First day of life" up to "24 months"
Blood pressure
Secondary outcome is blood pressure at a corrected age of one and two years.
Measured: "First day of life" up to "24 months"
BMI
Secondary outcome is BMI at five years of age, weight in kilograms and height in meters will be combined to report BMI in kg/m2
Measured: "First day of life" up to "five years"
Insulin sensitivity
Secondary outcome is insulin sensitivity at five years of age
Measured: "First day of life" up to "five years"
Lipid profile
Secondary outcome is lipid profile at five years of age
Measured: "First day of life" up to "five years"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start9 Oct 2020
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The NEO-VASC study is a multicentric, prospective, randomized, controlled, open and parallel group clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prolacta Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Vienna, Federal University Teaching Hospital, Feldkirch, Austria, Paracelsus Medical University
- Responsible party
- Principal investigator, Ursula Kohlendorfer, Medical University Innsbruck
- Investigators
- Ursula Kiechl-Kohlendorfer, MD, MSc, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413994
- Sponsor's protocol ID
- NEOVASC
- Other IDs
- 868624
- Acronym
- NEOVASC
- Status last verified
- Sep 2026
- First submitted
- 26 May 2020
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34332629
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Exclusive Human-milk Diet in Preterm NEOnates on Early VASCular Aging Risk Factors (NEOVASC)
- ClinicalTrials.gov ID
- NCT04413994
- Acronym / sponsor ID
- NEOVASC / NEOVASC
- Conditions
- Prematurity, Vascular Aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Prolacta BioscienceIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of Vienna, Federal University Teaching Hospital, Feldkirch, Austria, Paracelsus Medical University
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Early vascular aging has its origins in fetal and neonatal life. This early period of life plays an important role in the development of obesity, high blood pressure, abnormalities in lipid metabolism and non-insulin dependent diabetes. Increased cardiovascular risk in formerly preterm infants constitutes a health problem of steadily growing relevance. Emerging evidence suggests that human milk feeding has substantial benefits to the health of all infants, especially for those born prematurely. Unfortunately, human milk alone does not provide sufficient concentrations of nutrients, especially calcium, phosphorus, protein, and fat needed for these infants to grow satisfactorily. For that purpose, fortifiers are used to help increase the nutritional value of human milk.
The NEOVASC study is a multicentric, prospective, randomized, controlled, open and parallel group clinical trial. A total of 200 extremely preterm infants and 100 term infants are recruited for the test and control group, respectively. Infants in the test group (i.e., premature neonates) are randomized to either:
- An exclusive human milk diet which contains mother's milk or pasteurized donor human milk and a human milk fortifier until 36 weeks of gestation; OR
- Human milk (as long as available) and a 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. Participants within this control group are not enrolled at the time of birth but instead recruited in various kindergartens at the age of five. Therefore, data from birth is taken from the mother-child-booklet, which contains clinical records about the pregnancy, birth and early life of children born in Austria. The total study duration is scheduled for 96 months with a recruitment phase of 36 months. Follow-up visits are planned at one, two and five years of age for the test group.
The purpose of the NEOVASC clinical trial is to characterize early life stressors by assessing the effects of a physiological (i.e., human milk-based) nutrition in extremely preterm infants during the vulnerable preterm period on the risk of metabolic and vascular complications in later life. Outcomes include predictors and intermediate components of cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The NEO-VASC study is a multicentric, prospective, randomized, controlled, open and parallel group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Randomized study product group | Active comparator | Dietary Supplement: Humavantreceiving study product (human milk fortifier "Humavant") until a gestational age of 36 weeks |
| Randomized control group | Active comparator | Dietary Supplement: Humavantreceiving study product until a gestational age of 32 weeks and reference product (bovine based fortifier or bovine formula) after 32 weeks of gestation |
| Term control group | No intervention | –Term-born controls as a reference group for outcome parameters |
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HumavantPremature 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. | Dietary supplement | Randomized control group, Randomized study product group |
Primary outcome
Fasting blood glucose
Time frame: "First day of life" up to "five years of life"
Primary outcome is the difference in fasting blood glucose at five years of age
Blood pressure
Time frame: "First day of life" up to "five years"
Primary outcome is the difference in blood pressure at five years of age
Distensibility of aorta
Time frame: "First day of life" up to "five years"
Primary outcome is the difference in the distensibility of the descending aorta using validated echocardiographic protocols at five years of age
5 secondary outcomes
Fasting blood glucose
Time frame: "First day of life" up to "24 months"
Blood pressure
Time frame: "First day of life" up to "24 months"
BMI
Time frame: "First day of life" up to "five years"
Insulin sensitivity
Time frame: "First day of life" up to "five years"
Lipid profile
Time frame: "First day of life" up to "five years"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Derived from this study: PubMed 34332629Mitterer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ursula Kiechl-Kohlendorfer, MD, MSc principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humavant in people with Prematurity and Vascular Aging, run by Prolacta Bioscience at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ursula Kiechl-Kohlendorfer, MD, MSc (+43 512 504 27309, ursula.kohlendorfer@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose (time frame: "First day of life" up to "five years of life"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04413994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.