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Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants

RecruitingPhase 2Ages 24 Weeks - 29 WeeksAllMonash Medical Centre
NCT07254000 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Anakinra (Kineret®)
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Where

2 sites
Monash Children's Hospital
Clayton, Australia
Starship Children's Hospital
Grafton, New Zealand
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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