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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
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.
Medical University of Innsbruck
Innsbruck, Tyrol, Austria
RECRUITINGFasting blood glucose
Primary outcome is the difference in fasting blood glucose at five years of age
Time frame: "First day of life" up to "five years of life"
Blood pressure
Primary outcome is the difference in blood pressure at five years of age
Time frame: "First day of life" up to "five years"
Distensibility of aorta
Primary outcome is the difference in the distensibility of the descending aorta using validated echocardiographic protocols at five years of age
Time frame: "First day of life" up to "five years"
Fasting blood glucose
Secondary outcome is fasting glucose at a corrected age of one and two years.
Time frame: "First day of life" up to "24 months"
Blood pressure
Secondary outcome is blood pressure at a corrected age of one and two years.
Time frame: "First day of life" up to "24 months"
BMI
Secondary outcome is BMI at five years of age, weight in kilograms and height in meters will be combined to report BMI in kg/m2
Time frame: "First day of life" up to "five years"
Insulin sensitivity
Secondary outcome is insulin sensitivity at five years of age
Time frame: "First day of life" up to "five years"
Lipid profile
Secondary outcome is lipid profile at five years of age
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Time frame: "First day of life" up to "five years"