NCT04413994 (NEOVASC) is a NA clinical trial of Humavant in Prematurity, sponsored by Prolacta Bioscience.

Who is sponsoring NCT04413994?

NCT04413994 is sponsored by Prolacta Bioscience.

What drugs are being tested in NCT04413994?

Interventions in NCT04413994: Humavant.

What condition does NCT04413994 study?

NCT04413994 studies Prematurity, Vascular Aging.

Is NCT04413994 still recruiting?

NCT04413994 is currently recruiting now. Last updated 29 August 2025.

Last reviewed 2025-08-29 · How we verify

NCT04413994: NEOVASC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now NA Last updated 29 August 2025

What this trial tests

NA trial testing Humavant in Prematurity in 200 participants. Currently enrolling.

Timeline

9 October 2020

Primary endpoint
1 June 2028

1 June 2028

Quick facts

Lead sponsor	Prolacta Bioscience
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	200
Start date	9 October 2020
Primary completion	1 June 2028
Estimated completion	1 June 2028
Sites	1 location across Austria

Drugs / interventions tested

Humavant

Conditions studied

Prematurity — all drugs for Prematurity →
Vascular Aging — all drugs for Vascular Aging →

Sponsor

Prolacta Bioscience — full company profile →

Who can join

Adults 1 Day to 5, any sex, with Prematurity or Vascular Aging. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

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.
Mitterer W, Binder C, Blassnig-Ezeh A, Auer-Hackenberg L, et al · · 2021 · cited 2× · PMID 34332629 · DOI 10.1186/s13063-021-05445-9
Effects of a Prolonged Exclusive Human Milk-Based Diet on Structural and Functional Brain Maturation in Very Preterm Infants: An Ancillary Analysis of the NEOVASC Trial.
Mitterer W, Hochmayr C, Waltner-Romen M, Sappler M, et al · · 2026 · PMID 42123924 · DOI 10.3390/nu18091321

Verify or expand the search:

Other recruiting trials for Prematurity

Currently open trials in the same condition.

NCT06965530 — Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy · NA · recruiting
NCT06420531 — Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial · NA · recruiting
NCT07183462 — Azithromycin and Ampicillin for Late PPROM · Phase 4 · recruiting
NCT06536296 — The Impact of Music Medicine on Preterm Brain Development and Behavior · NA · recruiting
NCT07213414 — Metagenomic & Metabolomic Study: Bifidobacterium Probiotic Effects on Gut Microbiota & SCFA in Preterm NICU Infants · EARLY_PHASE1 · active not recruiting

Other Prolacta Bioscience trials

Trials by the same sponsor.

NCT06102213 — Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogenei · Phase 2 · terminated
NCT05141903 — Dietary Supplement With and Without a Probiotic and/or Antibiotic · completed
NCT04433208 — Dietary Supplement With and Without a Probiotic · NA · completed
NCT03793686 — A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea · Phase 1 · terminated
NCT05516225 — Safety Study of Human Milk Oligosaccharides in Healthy Adults · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04413994 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Prolacta Bioscience
Last refreshed: 29 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04413994.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing