Anakinra for Preterm Infants Pilot

Phase 1

Active, not recruiting

• Conditions: Prematurity; Extreme; Inflammation

• Registration Number: NCT05280340
• Lead Sponsor: Monash Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-2-1
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Inclusion Criteria:<br><br> - Born at 24 to 27+6 weeks gestation<br><br>Exclusion Criteria:<br><br> - Inability of the legal representatives to consent<br><br> - Any disease or condition that the investigators judge could confound the trial<br> results; these include, but are not limited to, genetic syndromes, severe cardiac<br> abnormalities, substantial pre-/perinatal compromise (profound/severe hypoxia (SaO2<br> <80% for >3h), congenital diaphragmatic hernia, intrauterine stroke and others.<br><br> - Imminent death

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related serious adverse reactions (suspected and unexpected)

Secondary Outcome Measures

Name	Time	Method
Plasma interleukin-1 receptor antagonist levels will be measured and reported in pg/mL for each participant conferred by treatment with anakinra