Study to Find the Best Dose and Method of Giving Anakinra to Very Premature Infants Born Between 24 and 28 Weeks

What this Trial Is About

Researchers are conducting a phase 2 randomized trial to study the safety, effectiveness, and best dose of intravenous anakinra in extremely premature infants born between 24 and 28 weeks of gestation. This trial builds on earlier research showing that inflammation, especially involving interleukin-1, plays a key role in complications of prematurity. The goal is to find optimal dosing and assess an alternative subcutaneous route while monitoring drug behavior and early effects on inflammation and health outcomes. The study includes 24 infants randomly assigned to one of three dosing groups, each receiving anakinra intravenously for 21 days or intravenously for 14 days followed by subcutaneous administration for 7 days. The trial aims to develop models of how the drug is cleared, distributed, and absorbed in these neonates to guide future dosing. Participants will also receive standard care throughout the study. During the 3-week treatment, researchers will monitor drug levels and model pharmacokinetics and pharmacodynamics, including biomarkers of inflammation and clinical outcomes like lung and brain health. Safety will be followed closely up to 4 weeks, with additional neurological and respiratory assessments at 4 to 6 months. The trial will help determine the best dose and route of anakinra administration for very premature infants.

Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants