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Active, Not Recruiting

NCT Number: NCT05280340

Anakinra for Preterm Infants Pilot

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prematurity; Extreme Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Inflammation Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

24 week–28 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Monash Health, Clayton, Victoria, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anakinra

Drug

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

Other names: Kineret

Primary outcomes

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

    Time frame: 3 weeks

    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.

Secondary outcomes

  1. Plasma interleukin-1 receptor antagonist levels will be measured and reported in pg/mL for each participant conferred by treatment with anakinra

    Time frame: 22 days

    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.

Sponsors and collaborators

Lead sponsor

Monash Medical Centre

Other

Collaborators

  • Hudson Institute of Medical Research
  • Monash University
  • Te Whatu Ora - Health New Zealand
  • University of Auckland, New Zealand

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 15, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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