Clinical trial NCT05280340: Anakinra for Preterm Infants Pilot
Official title: Advancing IL-1Ra to Prevent Inflammatory Disease in Preterm Infants - Pilot
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prematurity; Extreme
Inflammation
Keywords: anakinra
IL-1Ra
bronchopulmonary dysplasia
diffuse white matter injury
Lead sponsor: Monash Medical Centre
Sponsor class: OTHER
Collaborators: name: Monash University
name: Hudson Institute of Medical Research
name: Te Whatu Ora - Health New Zealand
name: University of Auckland, New Zealand
First posted: 2022-03-15
Enrollment: 25
Sex: ALL
Minimum age (years): 24
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dose escalation
Primary purpose: TREATMENT

Brief summary: Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.

Detailed description: With improvements in antenatal and neonatal care over the last 20 years, now infants are born as early as 22 weeks gestation and survive to discharge from hospital. This increased survival comes with increased risk of long term issues such as cerebral palsy and chronic lung disease. There is strong evidence to show these risks are increased due to an underlying inflammatory process initiated around the time of premature birth. This study aims to prove the safety of treating infants born between 24-27+6 weeks gestation with Anakinra, a medication which is similar to an anti-inflammatory molecule the body makes itself called Interleukin 1 Receptor Antagonist (IL-1Ra). Anakinra acts to reduce the inflammatory response and is currently used in adults and children as young as 8 months to manage autoimmune inflammatory conditions. This study looks at the safety of giving Anakinra to babies born extremely premature, over the first 3 weeks of life. Once safety is established, the investigators will conduct a larger trial studying the efficacy of this treatment for reducing the risk of long-term complications caused by neonatal inflammation in extremely preterm infants.

Eligibility criteria: Inclusion Criteria:

* Born at 24 to 27+6 weeks gestation

Exclusion Criteria:

* Inability of the legal representatives to consent
* Any disease or condition that the investigators judge could confound the trial results; these include, but are not limited to, genetic syndromes, severe cardiac abnormalities, substantial pre-/perinatal compromise (profound/severe hypoxia (SaO2 \<80% for \>3h), congenital diaphragmatic hernia, intrauterine stroke and others.
* Imminent death

Primary outcomes:
measure: Number of participants with treatment-related serious adverse reactions (suspected and unexpected)
timeFrame: 3 weeks
Secondary outcomes:
measure: Plasma interleukin-1 receptor antagonist levels will be measured and reported in pg/mL for each participant conferred by treatment with anakinra
timeFrame: 22 days
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Grafton
country: New Zealand
facility: Starship Children's Hospital, Te Whatu Ora - Health New Zealand
state: Auckland
Study officials:
affiliation: Monash University
name: Marcel Nold, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hudson Institute of Medical Research
name: Claudia Nold, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University
name: Rod Hunt, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hudson Institute of Medical Research
name: Rob Galinsky, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Starship Children's Hospital, Te Whatu Ora - Health New Zealand
name: Gergely Toldi, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Green EA, Metz D, Galinsky R, Atkinson R, Skuza EM, Clark M, Gunn AJ, Kirkpatrick CM, Hunt RW, Berger PJ, Nold-Petry CA, Nold MF. Anakinra Pilot - a clinical trial to demonstrate safety, feasibility and pharmacokinetics of interleukin 1 receptor antagonist in preterm infants. Front Immunol. 2022 Oct 27;13:1022104. doi: 10.3389/fimmu.2022.1022104. eCollection 2022.