Anakinra for Preterm Infants Pilot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2025-03-31

Brief Summary

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

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Detailed Description

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With improvements in antenatal and neonatal care over the last 20 years, now infants are born as early as 22 weeks gestation and survive to discharge from hospital. This increased survival comes with increased risk of long term issues such as cerebral palsy and chronic lung disease. There is strong evidence to show these risks are increased due to an underlying inflammatory process initiated around the time of premature birth. This study aims to prove the safety of treating infants born between 24-27+6 weeks gestation with Anakinra, a medication which is similar to an anti-inflammatory molecule the body makes itself called Interleukin 1 Receptor Antagonist (IL-1Ra). Anakinra acts to reduce the inflammatory response and is currently used in adults and children as young as 8 months to manage autoimmune inflammatory conditions. This study looks at the safety of giving Anakinra to babies born extremely premature, over the first 3 weeks of life. Once safety is established, the investigators will conduct a larger trial studying the efficacy of this treatment for reducing the risk of long-term complications caused by neonatal inflammation in extremely preterm infants.

Conditions

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Prematurity; Extreme Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Dose escalation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Anakinra

Intervention Type DRUG

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

Interventions

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Anakinra

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

Intervention Type DRUG

Other Intervention Names

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Kineret

Eligibility Criteria

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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

Minimum Eligible Age

24 Weeks

Maximum Eligible Age

28 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No