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Recruiting Phase 2 NCT07254000
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
Trial Parameters
Condition Premature Infants
Sponsor Monash Medical Centre
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 24
Sex ALL
Min Age 24 Weeks
Max Age 29 Weeks
Start Date 2025-06-27
Completion 2026-06
All Conditions
Interventions
Anakinra (Kineret®)
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Born between 24+0 and 28+6 weeks of gestation Exclusion Criteria: * Inability of the legal representatives to consent, * Genetic syndromes, * Severe cardiac anomalies, * Substantial pre-/perinatal compromise, * Congenital diaphragmatic hernia, * Intrauterine stroke, * Conditions that could confound trial results * Imminent death or plan for comfort / palliative care * Infants born outside the recruiting institutions