Parental Consent to a Neonatal Clinical Study: The Roles of Uncertainty, Burden of Sample Collection and Societal Expectations.
Susanne Soendergaard Kappel, Gustav Riemer Jakobsen, Kija Lin Oestergaard...
https://pubmed.ncbi.nlm.nih.gov/41051016Actively Recruiting
Early Phase 1
All Genders
ID05272579
PrePhage - Fecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants - Clinical Trial
Led by Rigshospitalet, Denmark · Updated on 2024-11-15
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
L
Lise Aunsholt, Neonatologist, Clinical Professor
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates the safety of transferring fecal bacteriophages and proteins from healthy full-term infants to preterm infants born between 26+0 and 30+6 weeks of gestational age. The goal is to develop a treatment to prevent necrotizing enterocolitis (NEC), a severe gut disease common in neonatal intensive care units that causes significant illness and death among preterm babies. The study explores the role of gut microbiota and bacteriophages in NEC development. The trial includes three stages: recruiting healthy donor infants to study their microbiota and collect fecal samples, testing safety and effects in preterm piglets, and finally administering fecal filtrate transfer (FFT) to preterm infants. Twenty preterm infants are randomly assigned to receive either FFT containing filtered viruses and proteins or a saline placebo via a nasogastric tube within 24 hours after birth and for the following three days. Participants are closely monitored clinically and biochemically for safety, including any serious adverse events within 14 days, and followed for three years to observe long-term effects. Outcomes measured include feeding tolerance, microbiota composition, growth parameters, stool characteristics, vital signs, and hospitalization duration. The trial aims to confirm safety and gather data to support larger future studies.
CONDITIONS
Brief Title
PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Preterm infants born between gestational age 26+0 and 30+6
- Delivered at Rigshospitalet or transferred to Rigshospitalet NICU within 24 hours of delivery
- Infants administered prophylactic antibiotics due to maternal risk factors such as premature rupture of membranes, group B streptococcus positive, or fever during labor
- Signed parental consent
- Mothers aged 18 to 45 years
- Mothers able to give informed consent
You will not qualify if you...
- Major congenital anomalies or birth defects
- Antibiotics administered to the infant for more than 72 hours after birth
- Extremely small for gestational age infant (weight standard deviation score less than -3 SD)
- Need for mechanical ventilation or cardiovascular support before first fecal filtrate transfer treatment
- Mothers with severe infection requiring treatments other than antibiotics, such as inotropic treatment or intravenous fluid resuscitation
AI-Screening
AI-Powered Screening
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2
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Your Study Journey
Screening
Duration - Up to 24 hours after birth
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 days
Participants receive either fecal filtrate transfer or saline placebo administered by nasogastric tube within the first 4 days after birth.
4 treatment administrations within 4 days and clinical monitoring
Follow-up
Duration - Up to 1 month
Participants are closely monitored clinically and biochemically for safety and development, including evaluation of feeding tolerance and gut health.
Regular clinical monitoring during hospitalization and assessments up to 1 month
Long-term Monitoring
Duration - 3 years
Participants are followed for up to 3 years to evaluate potential late side-effects and monitor changes in fecal microbiome after treatment or placebo.
Periodic assessments over 3 years
Trial Site Locations
Total: 1 location
1
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
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Research Team
G
Gustav R Jakobsen, md
L
Lise Aunsholt, md, phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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