Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorProlacta Bioscience
About this trial
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.
Eligibility criteria
Qualifiers
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.-
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Humavant
Treatment groups
200 Participants
are divided into 3 treatment groupsSponsors and collaborators
Prolacta Bioscience
Lead sponsor
Medical University Innsbruck
Sponsor institution
Medical University of Vienna
Collaborator
Federal University Teaching Hospital, Feldkirch, Austria
Collaborator
Paracelsus Medical University
Collaborator
Source ClinicalTrials.gov