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

Prolacta Bioscience

Status: Enrolling

Conditions: Prematurity; Vascular Aging

Treatments: Dietary Supplement: Humavant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04413994

868624 (Other Grant/Funding Number)

NEOVASC

Details and patient eligibility

About

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.

Full 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:

1. 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
2. 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1 day to 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Preterm-born group:

Inclusion Criteria:

1. Extremely preterm infants with a birth weight of 500-1250g.
2. Feeding is NPO or exclusive human milk prior to enrollment.
3. Parent(s) willing to sign informed consent.-

Exclusion Criteria:

1. Infants with a birth weight <500g or >1250g
2. Subjects diagnosed with inborn errors of metabolism such as galactosemia, phenylketonuria
3. Subjects who have not been NPO or fed exclusive human milk diet prior to enrollment.
4. Presence of major congenital malformation.
5. Presence of intestinal perforation or Stage 2 Necrotizing enterocolitis prior to enrollment.
6. Parent(s) not willing to sign informed consent.
7. 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

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 3 patient groups

Randomized study product group

Active Comparator group

Description:

receiving study product (human milk fortifier "Humavant") until a gestational age of 36 weeks

Treatment:

Dietary Supplement: Humavant

Randomized control group

Active Comparator group

Description:

receiving study product until a gestational age of 32 weeks and reference product (bovine based fortifier or bovine formula) after 32 weeks of gestation

Treatment:

Dietary Supplement: Humavant

Term control group

No Intervention group

Description:

Term-born controls as a reference group for outcome parameters