Status:
RECRUITING
Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)
Lead Sponsor:
Prolacta Bioscience
Collaborating Sponsors:
Medical University of Vienna
Federal University Teaching Hospital, Feldkirch, Austria
Conditions:
Prematurity
Vascular Aging
Eligibility:
All Genders
1-5 years
Phase:
NA
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 card...
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...
Eligibility Criteria
Inclusion
- Preterm-born group:
- 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.-
Exclusion
- 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:
- Inclusion criteria
- Term-born children with an adequate birth weight
- Parent(s) willing to sign informed consent
- Exclusion criteria
- Subjects with acute or chronic illness
- Parent(s) not willing to sign informed consent
Key Trial Info
Start Date :
October 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04413994
Start Date
October 9 2020
End Date
June 1 2028
Last Update
August 29 2025
Active Locations (1)
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1
Medical University of Innsbruck
Innsbruck, Tyrol, Austria, A-6020