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

What this Trial Is About

This research aims to understand how early life nutrition affects long-term cardiovascular health in extremely preterm infants. It focuses on the origins of early vascular aging, which starts in fetal and neonatal life and contributes to risks like obesity, high blood pressure, and abnormal metabolism. The study compares the effects of an exclusive human milk diet on these health risks in very premature babies. The trial also includes a control group of full-term children for comparison. The trial randomly assigns extremely preterm infants to one of two feeding groups: one receiving an exclusive human milk diet with a human milk fortifier until 36 weeks of gestation, and the other receiving human milk with fortifier until 32 weeks, then switching to human milk with a bovine-based fortifier or preterm formula. After 36 weeks, both groups receive human milk with bovine fortifier or preterm formula. The control group consists of term-born children matched by age, recruited at five years from kindergartens, with birth data collected from clinical records. Participants in the preterm groups are followed with visits at one, two, and five years of age, while term controls provide data at five years. The study evaluates fasting blood glucose, blood pressure, and aortic distensibility from birth to five years as primary outcomes. Secondary outcomes include body mass index, insulin sensitivity, and lipid profiles. The total study duration is planned for 96 months with a recruitment phase lasting 36 months.

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