Effects of an Exclusive Human-milk Diet in Preterm NEOnates on Early VASCular Aging Risk Factors (NEOVASC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Blood pressure
研究概览
简要总结
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.
详细描述
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:
- 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
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm-born group:
- •Inclusion Criteria:
- •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.-
排除标准
- •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
结局指标
主要结局
Blood pressure
时间窗: "First day of life" up to "five years"
Primary outcome is the difference in blood pressure at five years of age
Fasting blood glucose
时间窗: "First day of life" up to "five years of life"
Primary outcome is the difference in fasting blood glucose at five years of age
Blood pressure
时间窗: "First day of life" up to "five years"
Primary outcome is the difference in blood pressure at five years of age
Distensibility of aorta
时间窗: "First day of life" up to "five years"
Primary outcome is the difference in the distensibility of the descending aorta using validated echocardiographic protocols at five years of age
次要结局
- Blood pressure("First day of life" up to "24 months")
- Fasting blood glucose("First day of life" up to "24 months")
- BMI("First day of life" up to "five years")
- Insulin sensitivity("First day of life" up to "five years")
- Lipid profile("First day of life" up to "five years")
研究者
Ursula Kohlendorfer
Professor
Medical University Innsbruck