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Study on Darbepoetin Alfa for Reducing Brain Injury in Newborns with Perinatal Arterial Ischemic Stroke

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Perinatal Arterial Ischemic Stroke (PAIS), which affects newborns. The study aims to explore the potential benefits of a treatment called darbepoetin alfa, which is administered as a solution for injection. Darbepoetin alfa is a type of medication known as an erythropoiesis-stimulating agent, which is typically used to help the body produce more red blood cells. In this study, researchers are investigating whether darbepoetin alfa can help reduce brain injury in newborns who have experienced PAIS.

The study involves giving some infants darbepoetin alfa, while others will receive a placebo, which is a substance with no active medication. The purpose is to compare the effects of darbepoetin alfa with the placebo to see if there is a difference in the extent of brain injury. The study will monitor the infants from the time of the stroke until they are 6-8 weeks old, looking at changes in brain tissue and growth. Additionally, the study will assess the infants' development at 18 months of age, including their cognitive abilities and motor skills.

Participants in the study will be newborns who are at least 36 weeks old and have been diagnosed with PAIS through an MRI scan. The study will take place over several years, with the goal of finding a treatment that could potentially reduce or prevent the long-term effects of PAIS-related brain injury in newborns. By comparing the outcomes of those receiving darbepoetin alfa with those receiving a placebo, researchers hope to gather valuable information that could lead to improved treatments for this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting specific criteria: newborns must be at least 36 weeks gestation, have a confirmed diagnosis of acute perinatal arterial ischemic stroke (PAIS) through MRI, and be less than 4 days from the onset of symptoms. Written consent from the custodial parent(s) is required.
Step 2
Initial assessment
An initial assessment is conducted to confirm eligibility and establish baseline measurements. This includes MRI scans to evaluate the extent of the stroke and other relevant health checks.
Step 3
Treatment administration
The treatment involves the administration of darbepoetin alfa, a medication designed to stimulate the production of red blood cells. It is given as an injection using a pre-filled syringe containing 10 micrograms of the solution. The route of administration is intravenous, meaning it is delivered directly into a vein.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the infant's response to the treatment. This includes measuring changes in the size of the brain lesion and overall brain growth. These assessments occur between the time of the stroke and when the infant is 6-8 weeks old.
Step 5
Long-term evaluation
At 18 months of age, the infant's development is evaluated using various assessments. These include cognitive development tests and neurological assessments to determine motor function and hand abilities. The results are compared between those who received darbepoetin and those who received a placebo.

Who can join the trial?

4 criteria

The baby must be a newborn who is at least 36 weeks old at birth. This includes both boys and girls.
The baby must have a diagnosis of **acute PAIS** confirmed by an **MRI**. An MRI is a type of scan that helps doctors see inside the body.
The baby must show signs of the condition less than 4 days after symptoms start.
The baby's parents or guardians must give written permission for the baby to join the study.

Who cannot join the trial?

5 criteria

Infants who do not have a confirmed diagnosis of Perinatal Arterial Ischemic Stroke (PAIS) through an MRI scan cannot participate. An MRI is a type of scan that uses magnets and radio waves to create pictures of the inside of the body.
Infants who are not within the specific age range required for the study cannot participate. The study is focused on newborns.
Infants who have other medical conditions that might interfere with the study or its results cannot participate.
Infants who are already receiving treatments that might affect the study's outcomes cannot participate.
Infants whose parents or guardians do not give permission for them to be part of the study cannot participate.

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Universitair Medisch Centrum Utrecht
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Utrecht, The Netherlands

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Investigated drugs

Darbepoetin is a medication being studied for its potential to help infants who have experienced a type of stroke called perinatal arterial ischemic stroke (PAIS). This medication is part of a group of drugs known as erythropoiesis-stimulating agents (ESAs), which are typically used to encourage the production of red blood cells. In this clinical trial, researchers are investigating whether darbepoetin can reduce brain injury in newborns who have suffered from PAIS, with the hope of preventing or lessening the long-term effects of such brain injuries.

Darbepoetin Alfa

What is already known about the treatment

Darbepoetin – Darbepoetin is administered via injection and is currently being studied in clinical trials for its potential to treat perinatal arterial ischemic stroke (PAIS) in newborns. It is an erythropoiesis-stimulating agent (ESA) that is primarily used to stimulate the production of red blood cells. The main therapeutic indication being explored is its ability to reduce brain injury in neonates who have suffered from PAIS. At the molecular level, darbepoetin works by binding to erythropoietin receptors on the surface of red blood cell precursors, promoting their survival and proliferation. It is classified pharmacologically as an ESA, which is a type of medication that encourages the production of red blood cells.

Investigated diseases

Perinatal Arterial Ischemic Stroke (PAIS) – This condition occurs when there is a blockage in the blood vessels supplying the brain of a newborn, leading to reduced blood flow and oxygen to the brain tissue. It typically happens around the time of birth and can result in damage to the brain cells. The progression of PAIS can vary, with some infants experiencing significant brain injury while others may have milder effects. Over time, the affected brain tissue may shrink or change, which can be observed through imaging techniques like MRI. The condition can impact the infant's development, potentially affecting motor skills and cognitive abilities as they grow. Early detection and monitoring are crucial to understanding the extent of the injury and its potential impact on the child's development.