Giving protective particles from donor breast milk to very premature babies
Official title: Administration of Extracellular Vesicles Isolated From Donor Human Milk as a Dietary Supplement for the Prevention of Necrotizing Enterocolitis in Preterm Infants
Run by Instituto de Investigacion Sanitaria La Fe · NCT07402083 · Data updated 2026-11-12
This pilot will try giving extracellular vesicles from donor human milk to babies born before 32 weeks to see if it helps feeding and protects their intestines.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Days to 14 Days |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Instituto de Investigacion Sanitaria La Fe Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Status | Recruiting |
| Started | February 5, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2029 |
| Registry record updated | February 11, 2026 |
| Trial ID | NCT07402083 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are neonates born before 32 weeks' gestation, enrolled within 0–14 days of life, admitted to the NICU, and whose parents provide informed consent.
✕Probably not a fit
Infants with major congenital or chromosomal anomalies, severe gastrointestinal malformations, or conditions incompatible with enteral feeding are unlikely to receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
AdVEMPrem is a prospective, single-arm pilot enrolling 20 infants born before 32 weeks' gestation who are less than 14 days old and hospitalized in the NICU. All enrolled infants will receive oral supplementation with extracellular vesicles (EVs) isolated and quality-controlled from pasteurized donor human milk during their hospital stay. Researchers will monitor feeding tolerance, safety, and clinical signs of necrotizing enterocolitis, and will perform biochemical and lipid analyses of milk and EVs for exploratory correlations. The protocol focuses on feasibility and safety and includes standardized methods for EV isolation and product characterization.
Why it matters
Potential benefit: If successful, EV supplementation could improve feeding tolerance and reduce the risk or severity of necrotizing enterocolitis in very preterm infants.
How similar studies have gone: Preclinical laboratory and animal studies suggest milk-derived EVs reduce inflammation and support gut development, but clinical evidence in very preterm infants is currently lacking, making this among the first human pilot applications.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain Recruiting
Study contacts
- Study coordinator: Julia Kuligowski, PhD
- Email: julia.kuligowski@uv.es
- Phone: +34961246661
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.