Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorProlacta Bioscience
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.-
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Humavant
Dietary supplementPremature 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.
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: Randomized study product groupActive comparator 1 intervention
Group B: Randomized control groupActive comparator 1 intervention
Group C: Term control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Fasting blood glucose
Primary outcome is the difference in fasting blood glucose at five years of age
Time frame
"First day of life" up to "five years of life"2
Blood pressure
Primary outcome is the difference in blood pressure at five years of age
Time frame
"First day of life" up to "five years"3
Distensibility of aorta
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 outcomes
1
Fasting blood glucose
Secondary outcome is fasting glucose at a corrected age of one and two years.
Time frame
"First day of life" up to "24 months"2
Blood pressure
Secondary outcome is blood pressure at a corrected age of one and two years.
Time frame
"First day of life" up to "24 months"3
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
Time frame
"First day of life" up to "five years"4
Insulin sensitivity
Secondary outcome is insulin sensitivity at five years of age
Time frame
"First day of life" up to "five years"Other outcomes
1
Fasting blood glucose
Difference in fasting blood glucose between preterm- and term-born children at five years of age
Time frame
"five years of age"2
Blood pressure
Difference in blood pressure between preterm- and term-born children at five years of age
Time frame
"five years of age"3
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
Time frame
"five years of age"4
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
Time frame
"five years of age"Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Prolacta Bioscience
Lead sponsor
Medical University Innsbruck
Sponsor institution
Medical University of Vienna
Collaborator
Federal University Teaching Hospital, Feldkirch, Austria
Collaborator
Paracelsus Medical University
Collaborator
Source ClinicalTrials.gov