Clinical trial

Advancing IL-1Ra to Prevent Inflammatory Disease in Preterm Infants - Pilot

NCT05280340

Name

RES 21-0000-681A

Description

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

Trial arms

Trial start

2022-02-15

Estimated PCD

2024-09-01

Trial end

2025-02-01

Status

Recruiting

Phase

Early phase I

Treatment

Anakinra

Anakinra will be given to enrolled infants starting in the first 24hrs of life for the first 3 weeks of life.

Arms:

Anakinra

Other names:

Kineret

Size

Primary endpoint

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

3 weeks

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Dose escalation', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

Updated at

2023-08-15

1 organization

1 product

2 indications

Organization

Monash Medical Centre

Product

Anakinra

Indication

Prematurity

Indication

Inflammation