Anakinra for Preterm Infants Pilot

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Monash Medical Centre
• Collaborator: Monash University
• Treatments: Interleukin 1 Receptor Antagonist Protein

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