Effects of exclusive human milk on cardiovascular health in preterm infants
Effects of an Exclusive Human-milk Diet in Preterm NEOnates on Early VASCular Aging Risk Factors (NEOVASC)
This study tests if feeding extremely preterm infants only human milk can improve their heart health compared to those who get fortified human milk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 1 Day to 5 Years |
| Sex | All |
| Sponsor | Prolacta Bioscience Industry-sponsored |
| Locations | 1 site (Innsbruck, Tyrol) |
| Trial ID | NCT04413994 on ClinicalTrials.gov |
What this trial studies
The NEOVASC clinical trial investigates how an exclusive human milk diet impacts long-term cardiovascular health in extremely preterm infants. This multicentric, randomized, controlled trial will enroll 200 extremely preterm infants and 100 term infants, comparing the effects of an exclusive human milk diet with a fortified human milk diet. The study aims to address the nutritional needs of preterm infants while assessing the potential benefits of human milk on reducing early vascular aging and associated cardiovascular risks. Participants will be monitored until they reach 36 weeks of gestation to evaluate health outcomes.
Who should consider this trial
Good fit: Ideal candidates include extremely preterm infants with a birth weight between 500-1250g who are either NPO or on an exclusive human milk diet prior to enrollment.
Not a fit: Patients who may not benefit include those with a birth weight outside the specified range or those diagnosed with certain metabolic disorders or major congenital malformations.
Why it matters
Potential benefit: If successful, this study could significantly improve cardiovascular health outcomes for extremely preterm infants.
How similar studies have performed: Other studies have shown promising results regarding the benefits of human milk feeding in preterm infants, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Innsbruck, Tyrol
- Medical University of Innsbruck — Innsbruck, Tyrol, Austria (Recruiting)
Study contacts
- Principal investigator: Ursula Kiechl-Kohlendorfer, MD, MSc — Medical University Innsbruck
- Study coordinator: Ursula Kiechl-Kohlendorfer, MD, MSc
- Email: ursula.kohlendorfer@i-med.ac.at
- Phone: +43 512 504 27309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.