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New treatment option for Premature Infants
Official title Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
ClinicalTrials.gov ID: NCT07254000
What this study is testing
What is Anakinra (Kineret®)?
Anakinra (Kineret®) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for premature infants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 24 to 29
You may be able to join if
- Born between 24+0 and 28+6 weeks of gestation
You likely can't join if
- Inability of the legal representatives to consent,
- Genetic syndromes,
- Severe cardiac anomalies,
- Substantial pre-/perinatal compromise,
- Congenital diaphragmatic hernia,
- Intrauterine stroke,
See the full eligibility criteria
- Born between 24+0 and 28+6 weeks of gestation
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Clayton, Victoria, Australia
- Grafton, Auckland, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 24 weeks to 29 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clayton, Victoria, Australia; Grafton, Auckland, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.