Anakinra for Preterm Infants Pilot

Last updated: September 15, 2024
Sponsor: Monash Medical Centre
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Inflammation

Treatment

Anakinra

Clinical Study ID

NCT05280340
RES 21-0000-681A
  • Ages 24-28
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Born at 24 to 27+6 weeks gestation

Exclusion

Exclusion Criteria:

  • Inability of the legal representatives to consent

  • Any disease or condition that the investigators judge could confound the trialresults; these include, but are not limited to, genetic syndromes, severe cardiacabnormalities, substantial pre-/perinatal compromise (profound/severe hypoxia (SaO2 <80% for >3h), congenital diaphragmatic hernia, intrauterine stroke and others.

  • Imminent death

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Anakinra
Phase: 1/2
Study Start date:
February 15, 2022
Estimated Completion Date:
March 31, 2025

Study Description

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.

Connect with a study center

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Starship Children's Hospital, Te Whatu Ora - Health New Zealand

    Grafton, Auckland 1023
    New Zealand

    Site Not Available

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