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Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants

Recruitingn/aAges 0 Days - 14 DaysAllInstituto de Investigacion Sanitaria La Fe
NCT07402083 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing enterocolitis (NEC). NEC is a dangerous condition that affects the intestines of preterm infants and can lead to long-term health issues. Human milk is the best nutrition for babies, but when a mother's own milk is not available, donor human milk (DHM) is used. EVs in milk carry proteins, fats, and genetic material that may support gut development, immunity, and brain growth. While laboratory studies suggest EVs are beneficial, their effects in premature babies have not yet been proven. In this study, 20 very preterm infants (\<32 weeks of gestation) will be enrolled during their stay in the Neonatal Intensive Care Unit (NICU). All babies in the study will receive oral s

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📋 Eligibility rules (as published)
Inclusion Criteria: * Preterm infants born at \<32 weeks gestational age * Age between 0 and 14 days of life at enrollment * At risk of developing necrotizing enterocolitis (NEC) * Written informed consent obtained from parent(s) or legal guardian(s) Exclusion Criteria: * Major congenital anomalies or chromosomal abnormalities * Severe gastrointestinal malformations (e.g., gastroschisis, intestinal atresia) * Conditions incompatible with enteral feeding or EV supplementation * Participation in another interventional clinical trial
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What it tests

  • Donor human milk extracellular vesicles (DHM-EVs)
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Where

1 site
Hospital Universitario y Politécnico La Fe
Valencia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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