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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05280340
Ethics application status
Date submitted
1/02/2022
Date registered
15/03/2022
Date last updated
19/09/2024

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)
Assessment method [1] 0 0
Monitoring of vital signs and documentation of any significant adverse effects, for the duration of treatment which is 3 weeks, such as cardiorespiratory deterioration requiring escalation of therapy (need to start or increase inotropic medication), need for cardiopulmonary resuscitation, incidence of sepsis and death within 15mins of infusion. Continuously collected physiological data will be summarised as area under the curve in 24h epochs. Serum creatinine will be monitored for incidence of acute kidney injury on days 3, 7 and 14. Liver function will be monitored for incidence of drug-induced liver injury on days 3, 7 and 14.
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
Assessment method [1] 0 0
Blood will be taken prior to commencement of the trial medication, then at 6 \& 12hr post-dose on days 1 and 22 and 12hr post dose on day 3, 7 and 14 and the IL-1Ra level recorded in pg/mL.
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
Not applicable
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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
1/03/2025
Actual
Sample size
Target
Accrual to date
Final
25
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
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Hudson Institute of Medical Research
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Te Whatu Ora - Health New Zealand
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Auckland, New Zealand
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
Name 0 0
Marcel Nold, Prof
Address 0 0
Country 0 0
Phone 0 0
+61385723936
Email 0 0
marcel.nold@monash.edu
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05280340