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

Launched by PROLACTA BIOSCIENCE · May 30, 2020

Keywords

ClinConnect Summary

The NEOVASC clinical trial is studying how an exclusive human milk diet affects the long-term heart health of extremely preterm infants. Researchers believe that early nutrition can play a significant role in preventing issues related to vascular aging, which is the wear and tear on blood vessels that can start as early as in the womb. The trial is currently recruiting participants, specifically extremely preterm infants who weigh between 500 and 1250 grams and have been fed either nothing by mouth or only human milk before joining the study. Parents will need to provide consent for their children to participate.

Eligible participants will be monitored to see how this specific diet influences their cardiovascular health as they grow. The trial also includes a group of full-term children with normal birth weights to compare results. It's important for parents to know that not all infants will qualify; for example, those with certain health conditions or who are not being fed exclusively with human milk will be excluded. If you think your child might be eligible and are interested in learning more, talking to your healthcare provider can help you understand the study better.

Gender

ALL

Eligibility 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