NCT05280340

Anakinra for Preterm Infants Pilot

Advancing IL-1Ra to Prevent Inflammatory Disease in Preterm Infants - Pilot

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Monash Medical Centre · Academic / Other
• Sex: All
• Age: 24 Weeks – 28 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Prematurity; Extreme
• Inflammation

Interventions

Type	Name	Description
DRUG	Anakinra	Anakinra will be given to enrolled infants starting in the first 24hrs of life for the first 3 weeks of life.

Timeline

• Start date: 2022-02-15
• Primary completion: 2024-03-21
• Completion: 2025-03-01
• First posted: 2022-03-15
• Last updated: 2024-09-19

Locations

2 sites across 2 countries: Australia, New Zealand