Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05280340




Registration number
NCT05280340
Ethics application status
Date submitted
1/02/2022
Date registered
15/03/2022
Date last updated
15/08/2023

Titles & IDs
Public title
Anakinra for Preterm Infants Pilot
Scientific title
Advancing IL-1Ra to Prevent Inflammatory Disease in Preterm Infants - Pilot
Secondary ID [1] 0 0
RES 21-0000-681A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity; Extreme 0 0
Inflammation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Anakinra

Experimental: Anakinra - First 6 enrolled infants given 1.0mg/kg anakinra alternate daily IV for first 3 weeks of life.
Remaining 18 enrolled infants given 0.8mg/kg anakinra daily IV for the first 3 weeks of life, if infant is = 26 weeks gestation.
If infant is < 26 weeks gestation, dosing of 1.0mg/kg anakinra alternate daily IV for the first 3 weeks of life, will continue (3 infants only).


Treatment: Drugs: Anakinra
Anakinra will be given to enrolled infants starting in the first 24hrs of life for the first 3 weeks of life.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related serious adverse reactions (suspected and unexpected)
Timepoint [1] 0 0
3 weeks
Secondary outcome [1] 0 0
Plasma interleukin-1 receptor antagonist levels will be measured and reported in pg/mL for each participant conferred by treatment with anakinra
Timepoint [1] 0 0
22 days

Eligibility
Key inclusion criteria
- Born at 24 to 27+6 weeks gestation
Minimum age
24 Weeks
Maximum age
28 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Monash Medical Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Hudson Institute of Medical Research
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Te Whatu Ora - Health New Zealand
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Auckland, New Zealand
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely
premature infants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05280340
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marcel Nold, Prof
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marcel Nold, Prof
Address 0 0
Country 0 0
Phone 0 0
+61385723936
Fax 0 0
Email 0 0
marcel.nold@monash.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05280340