Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC) (NEOVASC)
Primary Purpose
Prematurity, Vascular Aging
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Humavant
Sponsored by
About this trial
This is an interventional treatment trial for Prematurity
Eligibility Criteria
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.-
Exclusion Criteria:
- 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
Sites / Locations
- Medical University of InnsbruckRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Randomized study product group
Randomized control group
Term control group
Arm Description
receiving study product (human milk fortifier "Humavant") until a gestational age of 36 weeks
receiving study product until a gestational age of 32 weeks and reference product (bovine based fortifier or bovine formula) after 32 weeks of gestation
Term-born controls as a reference group for outcome parameters
Outcomes
Primary Outcome Measures
Fasting blood glucose
Primary outcome is the difference in fasting blood glucose at five years of age
Blood pressure
Primary outcome is the difference in blood pressure at five years of age
Distensibility of aorta
Primary outcome is the difference in the distensibility of the descending aorta using validated echocardiographic protocols at five years of age
Secondary Outcome Measures
Fasting blood glucose
Secondary outcome is fasting glucose at a corrected age of one and two years.
Blood pressure
Secondary outcome is blood pressure at a corrected age of one and two years.
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
Insulin sensitivity
Secondary outcome is insulin sensitivity at five years of age
Lipid profile
Secondary outcome is lipid profile at five years of age
Full Information
NCT ID
NCT04413994
First Posted
May 26, 2020
Last Updated
October 2, 2022
Sponsor
Prolacta Bioscience
Collaborators
Medical University of Vienna, Federal University Teaching Hospital, Feldkirch, Austria, Paracelsus Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04413994
Brief Title
Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)
Acronym
NEOVASC
Official Title
Effects of an Exclusive Human-milk Diet in Preterm NEOnates on Early VASCular Aging Risk Factors (NEOVASC)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
June 1, 2028 (Anticipated)
Study Completion Date
June 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prolacta Bioscience
Collaborators
Medical University of Vienna, Federal University Teaching Hospital, Feldkirch, Austria, Paracelsus Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Vascular Aging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The NEO-VASC study is a multicentric, prospective, randomized, controlled, open and parallel group clinical trial.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Randomized study product group
Arm Type
Active Comparator
Arm Description
receiving study product (human milk fortifier "Humavant") until a gestational age of 36 weeks
Arm Title
Randomized control group
Arm Type
Active Comparator
Arm 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
Arm Title
Term control group
Arm Type
No Intervention
Arm Description
Term-born controls as a reference group for outcome parameters
Intervention Type
Dietary Supplement
Intervention Name(s)
Humavant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fasting blood glucose
Description
Primary outcome is the difference in fasting blood glucose at five years of age
Time Frame
"First day of life" up to "five years"
Title
Blood pressure
Description
Primary outcome is the difference in blood pressure at five years of age
Time Frame
"First day of life" up to "five years"
Title
Distensibility of aorta
Description
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"
Secondary Outcome Measure Information:
Title
Fasting blood glucose
Description
Secondary outcome is fasting glucose at a corrected age of one and two years.
Time Frame
"First day of life" up to "24 months"
Title
Blood pressure
Description
Secondary outcome is blood pressure at a corrected age of one and two years.
Time Frame
"First day of life" up to "24 months"
Title
BMI
Description
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"
Title
Insulin sensitivity
Description
Secondary outcome is insulin sensitivity at five years of age
Time Frame
"First day of life" up to "five years"
Title
Lipid profile
Description
Secondary outcome is lipid profile at five years of age
Time Frame
"First day of life" up to "five years"
Other Pre-specified Outcome Measures:
Title
Fasting blood glucose
Description
Difference in fasting blood glucose between preterm- and term-born children at five years of age
Time Frame
"five years of age"
Title
Blood pressure
Description
Difference in blood pressure between preterm- and term-born children at five years of age
Time Frame
"five years of age"
Title
Distensibility of the descending aorta
Description
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
Time Frame
"five years of age"
Title
BMI
Description
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
Time Frame
"five years of age"
Title
Insulin sensitivity
Description
Difference in insulin sensitivity between preterm- and term-born children at five years of age
Time Frame
"five years of age"
Title
Lipid profile
Description
Difference in lipid profile between preterm- and term-born children at five years of age
Time Frame
"five years of age"
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.-
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ursula Kiechl-Kohlendorfer, MD, MSc
Phone
+43 512 504 27309
Email
ursula.kohlendorfer@i-med.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Wolfgang Mitterer, MD
Phone
+43 670 2021490
Email
wolfgang.mitterer@student.i-med.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Kiechl-Kohlendorfer, MD, MSc
Organizational Affiliation
Medical University of Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
A-6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ursula Kiechl-Kohlendorfer, MD, MSc
Phone
+43 512 504 27309
Email
ursula.kohlendorfer@i-med.ac.at
First Name & Middle Initial & Last Name & Degree
Wolfgang Mitterer, MD
Email
wolfgang.mitterer@student.i-med.ac.at
First Name & Middle Initial & Last Name & Degree
Christoph Binder, MD
First Name & Middle Initial & Last Name & Degree
Martin Wald, MD
First Name & Middle Initial & Last Name & Degree
Burkhard Simma, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34332629
Citation
Mitterer W, Binder C, Blassnig-Ezeh A, Auer-Hackenberg L, Berger A, Simma B, Wald M, Lee M, Kiechl-Kohlendorfer U. Effects of an exclusive human-milk diet in preterm neonates on early vascular aging risk factors (NEOVASC): study protocol for a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial. Trials. 2021 Jul 31;22(1):509. doi: 10.1186/s13063-021-05445-9.
Results Reference
derived
Learn more about this trial
Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)
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