Status:
RECRUITING
PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Lise Aunsholt, Neonatologist, Clinical Professor
Conditions:
Necrotizing Enterocolitis
Microbial Substitution
Eligibility:
All Genders
Phase:
EARLY_PHASE1
Brief Summary
PrePhage - Fecal bacteriophage transfer for enhanced gastrointestinal tract maturation in preterm infants This pilot triol has the primary goal of demonstrating the safety of transferring viruses and...
Detailed Description
PrePhage - Fecal bacteriophage transfer for enhanced gastrointestinal tract maturation in preterm infants This pilot trial aims to investigate if fecal filtrate transfers (FFT) to preterm infants is ...
Eligibility Criteria
Inclusion
- Inclusion criteria for participant preterm infants
- Preterm infants born between GA 26+0 and 30+6
- Delivery at RH or transferred to RH NICU within 24 hours of delivery
- Children administered prophylactic antibiotics due to maternal risk factors, specifically: premature rupture of membranes, groub b streptococcus positive, feber during labour
- Signed parental consent
- Exclusion criteria for participant preterm infants
- Major congenital anomalies or birth defects
- Antibiotics for more than 72 hours after birthExtremely SGA infant (weight SD score \< -3 SD)
- Need for mechanical ventilation or cardiovascular support before first FFT treatment
- Inclusion criteria for mothers of participants
- Women aged 18-45
- Ability to give informed consent
- Exclusion criteria for participant mothers
- ● Mothers who have severe infection, defined by need for other treatment to support infection-related comorbidities, besides from antibiotics (e.g. inotropic treatment, iv fluid resuscitation)
Exclusion
Key Trial Info
Start Date :
November 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05272579
Start Date
November 7 2023
End Date
December 31 2025
Last Update
November 15 2024
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100