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New study aims to calm inflammation in preterm infants

NCT ID NCT07254000

Disease control Sponsor: Monash Medical Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for very premature babies (born between 24 and 29 weeks) to find the safest and most effective dose of a medicine called anakinra, which helps reduce inflammation. About 24 infants will receive anakinra through an IV or a shot under the skin. Researchers will measure how the drug moves through the body and check for early signs of lung and brain health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

24 to 29 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia Inflammation inflammatory disease Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammation Premature infants Very premature infants

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Monash Children's Hospital

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Starship Children's Hospital

    NOT_YET_RECRUITING

    Grafton, Auckland, 1023, New Zealand

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