Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-14
SponsorInstituto de Investigacion Sanitaria La Fe
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Preterm infants at risk of developing necrotizing enterocolitis (NEC), recruited between 14 and 28 days of life during their stay in the Neonatal Intensive Care Unit (NICU). A total of 20 infants will be enrolled to receive oral administration of extracellular vesicles (EVs) isolated from donor human milk (DHM) as a dietary supplement.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Donor human milk extracellular vesicles (DHM-EVs)
Dietary supplementInfants born before 32 weeks of gestation will receive supplementation with extracellular vesicles isolated from donor human milk, in addition to standard nutritional care.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: EV supplementation in very preterm infants1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-related serious adverse events
Safety will be evaluated by the number of participants experiencing one or more treatment-related serious adverse events, defined as any of the following: (i) necrotizing enterocolitis (Bell stage ≥ II); (ii) metabolic or renal complications requiring medical intervention, (iii) cholestasis, or (iv) culture-proven sepsis. Participants experiencing multiple events will be counted once.
Time frame
From enrollment until term-equivalent age (i.e., up to 40 weeks postmenstrual age)2
Tolerance of donor human milk EV supplementation
Feeding tolerance is evaluated by the number of participants without clinical signs of gastrointestinal symptoms and successful progression of enteral feeding.
Time frame
From enrollment until term-equivalent age (i.e., up to 40 weeks postmenstrual age)Secondary outcomes
1
Infant weight
Measurements of weight (grams)
Time frame
From enrollment until term-equivalent age (weekly) and at 3, 6, 12, 18, and 24 months of corrected age2
Infant length
Measurements of length (cm)
Time frame
From enrollment until term-equivalent age (weekly) and at 3, 6, 12, 18, and 24 months of corrected age3
Infant head circumference
Measurement of head circumference (cm)
Time frame
From enrollment until term-equivalent age (weekly) and at 3, 6, 12, 18, and 24 months of corrected age4
Analysis of redox status biomarkers
Evaluation of the ratio reduced/oxidized glutathione
Time frame
21 days of lifeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Instituto de Investigacion Sanitaria La Fe
Lead sponsor
Hospital Universitario La Fe
Collaborator
Source ClinicalTrials.gov