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

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ClinicalTrials.gov Identifier: NCT04413994
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
Medical University of Vienna
Federal University Teaching Hospital, Feldkirch, Austria
Paracelsus Medical University
Information provided by (Responsible Party):
Ursula Kohlendorfer, Medical University Innsbruck

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.

Condition or disease Intervention/treatment Phase
Prematurity Vascular Aging Dietary Supplement: Humavant Not Applicable

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:

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The NEO-VASC study is a multicentric, prospective, randomized, controlled, open and parallel group clinical trial.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of an Exclusive Human-milk Diet in Preterm NEOnates on Early VASCular Aging Risk Factors (NEOVASC)
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2028
Estimated Study Completion Date : June 1, 2028

Arm Intervention/treatment
Active Comparator: Randomized study product group
receiving study product (human milk fortifier "Humavant") until a gestational age of 36 weeks
Dietary Supplement: Humavant

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.


Active Comparator: Randomized control group
receiving study product until a gestational age of 32 weeks and reference product (bovine based fortifier or bovine formula) after 32 weeks of gestation
Dietary Supplement: Humavant

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.


No Intervention: Term control group
Term-born controls as a reference group for outcome parameters



Primary Outcome Measures :
  1. Fasting blood glucose [ Time Frame: "First day of life" up to "five years" ]
    Primary outcome is the difference in fasting blood glucose at five years of age

  2. Blood pressure [ Time Frame: "First day of life" up to "five years" ]
    Primary outcome is the difference in blood pressure at five years of age

  3. Distensibility of aorta [ Time Frame: "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


Secondary Outcome Measures :
  1. Fasting blood glucose [ Time Frame: "First day of life" up to "24 months" ]
    Secondary outcome is fasting glucose at a corrected age of one and two years.

  2. Blood pressure [ Time Frame: "First day of life" up to "24 months" ]
    Secondary outcome is blood pressure at a corrected age of one and two years.

  3. BMI [ Time Frame: "First day of life" up to "five years" ]
    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

  4. Insulin sensitivity [ Time Frame: "First day of life" up to "five years" ]
    Secondary outcome is insulin sensitivity at five years of age

  5. Lipid profile [ Time Frame: "First day of life" up to "five years" ]
    Secondary outcome is lipid profile at five years of age


Other Outcome Measures:
  1. Fasting blood glucose [ Time Frame: "five years of age" ]
    Difference in fasting blood glucose between preterm- and term-born children at five years of age

  2. Blood pressure [ Time Frame: "five years of age" ]
    Difference in blood pressure between preterm- and term-born children at five years of age

  3. Distensibility of the descending aorta [ Time Frame: "five years of age" ]
    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

  4. BMI [ Time Frame: "five years of age" ]
    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

  5. Insulin sensitivity [ Time Frame: "five years of age" ]
    Difference in insulin sensitivity between preterm- and term-born children at five years of age

  6. Lipid profile [ Time Frame: "five years of age" ]
    Difference in lipid profile between preterm- and term-born children at five years of age



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413994


Contacts
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Contact: Ursula Kiechl-Kohlendorfer, MD, MSc +43 512 504 27309 ursula.kohlendorfer@i-med.ac.at
Contact: Wolfgang Mitterer, MD +43 670 2021490 wolfgang.mitterer@student.i-med.ac.at

Locations
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Austria
Medical University of Innsbruck
Innsbruck, Tyrol, Austria, A-6020
Contact: Ursula Kiechl-Kohlendorfer, MD, MSc    +43 512 504 27309    ursula.kohlendorfer@i-med.ac.at   
Contact: Wolfgang Mitterer, MD       wolfgang.mitterer@student.i-med.ac.at   
Principal Investigator: Christoph Binder, MD         
Principal Investigator: Martin Wald, MD         
Principal Investigator: Burkhard Simma, MD         
Sponsors and Collaborators
Prolacta Bioscience
Medical University of Vienna
Federal University Teaching Hospital, Feldkirch, Austria
Paracelsus Medical University
Investigators
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Principal Investigator: Ursula Kiechl-Kohlendorfer, MD, MSc Medical University of Innsbruck
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Responsible Party: Ursula Kohlendorfer, Professor, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT04413994    
Other Study ID Numbers: NEOVASC
868624 ( Other Grant/Funding Number: Austrian Research Promotion Agency )
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications