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

Prematurity Clinical Trial

— NEOVASC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04413994
• Other study ID #: NEOVASC
• Secondary ID: 868624
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2020
• Est. completion date: June 1, 2028

Study information

• Verified date: November 2023
• Source: Prolacta Bioscience
• Contact: Ursula Kiechl-Kohlendorfer, MD, MSc
• Phone: +43 512 504 27309
• Email: ursula.kohlendorfer[@]i-med.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Prematurity
• Vascular Aging

Intervention

Dietary Supplement:
• Humavant
Premature infants are randomized to either: 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 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.

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck	Tyrol

Sponsors (4)

Lead Sponsor	Collaborator
Prolacta Bioscience	Federal University Teaching Hospital, Feldkirch, Austria, Medical University of Vienna, Paracelsus Medical University

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting blood glucose	Difference in fasting blood glucose between preterm- and term-born children at five years of age	"five years of age"
Other	Blood pressure	Difference in blood pressure between preterm- and term-born children at five years of age	"five years of age"
Other	Distensibility of the descending aorta	Difference in the distensibility of the descending aorta between preterm- and term-born children using validated echocardiographic protocols at five years of age Results will be compared to results of term-born children	"five years of age"
Other	BMI	Difference in BMI between preterm- and term-born children at five years of age, weight in kilograms and height in meters will be combined to report BMI in kg/m2	"five years of age"
Other	Insulin sensitivity	Difference in insulin sensitivity between preterm- and term-born children at five years of age	"five years of age"
Other	Lipid profile	Difference in lipid profile between preterm- and term-born children at five years of age	"five years of age"
Primary	Fasting blood glucose	Primary outcome is the difference in fasting blood glucose at five years of age	"First day of life" up to "five years"
Primary	Blood pressure	Primary outcome is the difference in blood pressure at five years of age	"First day of life" up to "five years"
Primary	Distensibility of aorta	Primary outcome is the difference in the distensibility of the descending aorta using validated echocardiographic protocols at five years of age	"First day of life" up to "five years"
Secondary	Fasting blood glucose	Secondary outcome is fasting glucose at a corrected age of one and two years.	"First day of life" up to "24 months"
Secondary	Blood pressure	Secondary outcome is blood pressure at a corrected age of one and two years.	"First day of life" up to "24 months"
Secondary	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	"First day of life" up to "five years"
Secondary	Insulin sensitivity	Secondary outcome is insulin sensitivity at five years of age	"First day of life" up to "five years"
Secondary	Lipid profile	Secondary outcome is lipid profile at five years of age	"First day of life" up to "five years"