RecruitingNot ApplicableNCT04413994

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

Effects of an Exclusive Human-milk Diet in Preterm NEOnates on Early VASCular Aging Risk Factors (NEOVASC)

Sponsor

Prolacta Bioscience

Enrollment

200 participants

Start Date

Oct 9, 2020

Study Type

INTERVENTIONAL

Conditions

Prematurity Vascular Aging

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.

Eligibility

Min Age: 1 DayMax Age: 5 Years

Inclusion Criteria6

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.-
Term-born children with an adequate birth weight
Parent(s) willing to sign informed consent

Exclusion Criteria10

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:
Subjects with acute or chronic illness
Parent(s) not willing to sign informed consent

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Interventions

DIETARY_SUPPLEMENTHumavant

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.