Anakinra for Preterm Infants Pilot
NCT05280340 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2024-09-19
Summary
Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.
Conditions
- Prematurity; Extreme
- Inflammation
Interventions
- DRUG
-
Anakinra
Anakinra will be given to enrolled infants starting in the first 24hrs of life for the first 3 weeks of life.
Sponsors & Collaborators
- collaborator OTHER
-
Hudson Institute of Medical Research
collaborator UNKNOWN -
Te Whatu Ora - Health New Zealand
collaborator UNKNOWN -
University of Auckland, New Zealand
collaborator OTHER -
Monash Medical Centre
lead OTHER
Principal Investigators
-
Marcel Nold, Prof · Monash University
-
Claudia Nold, Prof · Hudson Institute of Medical Research
-
Rod Hunt, Prof · Monash University
-
Rob Galinsky, Dr · Hudson Institute of Medical Research
-
Gergely Toldi, Dr · Starship Children's Hospital, Te Whatu Ora - Health New Zealand
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 24 Weeks
- Max Age
- 28 Weeks
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-15
- Primary Completion
- 2024-03-21
- Completion
- 2025-03-31
Countries
- Australia
- New Zealand
Study Locations
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