Status:
ACTIVE_NOT_RECRUITING
Anakinra for Preterm Infants Pilot
Lead Sponsor:
Monash Medical Centre
Collaborating Sponsors:
Monash University
Hudson Institute of Medical Research
Conditions:
Prematurity; Extreme
Inflammation
Eligibility:
All Genders
24-28 years
Phase:
PHASE1
PHASE2
Brief Summary
Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.
Detailed Description
With improvements in antenatal and neonatal care over the last 20 years, now infants are born as early as 22 weeks gestation and survive to discharge from hospital. This increased survival comes with ...
Eligibility Criteria
Inclusion
- Born at 24 to 27+6 weeks gestation
Exclusion
- Inability of the legal representatives to consent
- Any disease or condition that the investigators judge could confound the trial results; these include, but are not limited to, genetic syndromes, severe cardiac abnormalities, substantial pre-/perinatal compromise (profound/severe hypoxia (SaO2 \<80% for \>3h), congenital diaphragmatic hernia, intrauterine stroke and others.
- Imminent death
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05280340
Start Date
February 15 2022
End Date
March 1 2025
Last Update
September 19 2024
Active Locations (2)
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1
Monash Health
Clayton, Victoria, Australia, 3168
2
Starship Children's Hospital, Te Whatu Ora - Health New Zealand
Grafton, Auckland, New Zealand, 1023