Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants

Recruiting now

Conditions studied: Very Preterm Infants (<32 Weeks of Gestation)

In brief

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 supplementation with EVs isolated from donor human milk. Researchers will monitor feeding tolerance, growth, intestinal health, and early development. Blood and urine samples will also be collected to study how EVs affect metabolism and stress markers. The main goal is to see if EV supplementation is safe and well tolerated. Longer-term follow-up will explore whether EVs improve growth and neurodevelopment as the babies grow. This research could lead to new nutritional strategies to reduce NEC and improve outcomes for premature infants and their families.

Key facts

Study ID

NCT07402083

Run by

Instituto de Investigacion Sanitaria La Fe

People needed

20

Starts

2026-02-05

Expected to finish

2029-12-31

Last updated by the study team

2026-02-11

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Hospital Universitario y Politécnico La Fe — Valencia, Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

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