Anakinra for Preterm Infants Pilot

Monash Medical Centre

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Inflammation; Prematurity; Extreme

Treatments: Drug: Anakinra

Study type: Interventional

Funder types: Other

Identifiers

NCT05280340

RES 21-0000-681A

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 24 to 28 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Anakinra

Experimental group

Description:

First 6 enrolled infants given 1.0mg/kg anakinra alternate daily IV for first 3 weeks of life. Remaining 18 enrolled infants given 0.8mg/kg anakinra daily IV for the first 3 weeks of life, if infant is ≥ 26 weeks gestation. If infant is \< 26 weeks gestation, dosing of 1.0mg/kg anakinra alternate daily IV for the first 3 weeks of life, will continue (3 infants only).

Treatment:

Drug: Anakinra