Actively Recruiting
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
Led by Monash Medical Centre · Updated on 2025-11-28
24
Participants Needed
2
Research Sites
74 weeks
Total Duration
On this page
Sponsors
M
Monash Medical Centre
Lead Sponsor
M
Monash University
Collaborating Sponsor
AI-Summary
What this Trial Is About
A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.
CONDITIONS
Official Title
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born between 24 weeks 0 days and 28 weeks 6 days of gestation
You will not qualify if you...
- Legal representatives unable to provide consent
- Presence of genetic syndromes
- Severe cardiac anomalies
- Significant pre- or perinatal compromise
- Congenital diaphragmatic hernia
- Intrauterine stroke
- Conditions that could affect trial results
- Imminent death or plan for comfort/palliative care
- Infants born outside the recruiting institutions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Monash Children's Hospital
Clayton, Victoria, Australia, 3168
Actively Recruiting
2
Starship Children's Hospital
Grafton, Auckland, New Zealand, 1023
Not Yet Recruiting
Research Team
M
Marcel F Nold, Prof
CONTACT
C
Claudia Nold, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
6
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