Anakinra for Preterm Infants Pilot

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05280340
• Other study ID #: RES 21-0000-681A
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 15, 2022
• Est. completion date: February 2025

Study information

• Verified date: December 2022
• Source: Monash Medical Centre
• Contact: Marcel Nold, Prof
• Phone: +61385723936
• Email: marcel.nold[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: February 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 28 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Prematurity; Extreme

Intervention

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

Locations

Country	Name	City	State
Australia	Monash Health	Clayton	Victoria
New Zealand	Starship Children's Hospital, Te Whatu Ora - Health New Zealand	Grafton	Auckland

Sponsors (5)

Lead Sponsor	Collaborator
Monash Medical Centre	Hudson Institute of Medical Research, Monash University, Te Whatu Ora - Health New Zealand, University of Auckland, New Zealand

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related serious adverse reactions (suspected and unexpected)	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.	3 weeks
Secondary	Plasma interleukin-1 receptor antagonist levels will be measured and reported in pg/mL for each participant conferred by treatment with anakinra	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.	22 days