Anakinra: Anakinra will be given to enrolled infants starting in the first 24hrs of life for the first 3 weeks of life.
Study summary
Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.
Eligibility
Sex
ALL
Min age
24 Weeks
Max age
28 Weeks
Healthy volunteers
No
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
Primary outcome measure(s)
Number of participants with treatment-related serious adverse reactions (suspected and unexpected) — 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.
Trial sites (2)
Facility
City
Region
Status
Monash Health
Clayton
Victoria
Starship Children's Hospital, Te Whatu Ora - Health New Zealand
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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