Effects of exclusive human milk on cardiovascular health in preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.