RecruitingPhase 2NCT07254000

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

Sponsor

Monash Medical Centre

Enrollment

24 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

Very premature infants Premature infants Inflammation

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

Min Age: 24 WeeksMax Age: 29 Weeks

Inclusion Criteria1

Born between 24+0 and 28+6 weeks of gestation

Exclusion Criteria9

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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Interventions

DRUGAnakinra (Kineret®)

Standard care plus Anakinra for 21 days

Locations(2)

Monash Children's Hospital

Clayton, Victoria, Australia

Starship Children's Hospital

Grafton, Auckland, New Zealand

View Full Details on ClinicalTrials.gov

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NCT07254000

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