Study on Allopurinol Sodium for Brain Injury Prevention in Newborns with Critical Congenital Heart Disease Undergoing Heart Surgery

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What is this study about?

This clinical trial is focused on studying brain injury in newborns with critical congenital heart disease who need heart surgery using a method called cardiopulmonary bypass. The treatment being tested is a medication called allopurinol sodium, which is given as a solution through a vein. The study will compare the effects of allopurinol sodium to a placebo to see if it can reduce brain injury in these newborns.

The purpose of the study is to find out if giving allopurinol sodium shortly after birth and around the time of heart surgery can help protect the brain from injury. The study will involve monitoring the newborns before and after surgery using various methods, including MRI scans to check for brain injury, and other tests to assess brain and heart function. The study will also look at the overall development of the children as they grow, including their movement and cognitive skills at different ages.

Throughout the study, researchers will gather information on how well allopurinol sodium works and its cost-effectiveness. The study aims to provide valuable insights into whether this treatment can improve outcomes for newborns with critical congenital heart disease undergoing surgery.

1 joining the study

Participation begins after a confirmed diagnosis of critical congenital heart disease in a newborn, requiring cardiac surgery with cardiopulmonary bypass within the first four weeks of life.

2 medication administration

The newborn receives either allopurinol sodium or a placebo (mannitol) intravenously. This is done to assess the potential reduction of brain injury after surgery.

The medication is administered as a solution for infusion.

3 surgery and monitoring

Cardiac surgery with cardiopulmonary bypass is performed. During this period, brain function and oxygenation are monitored using electroencephalogram and near-infrared spectroscopy.

4 postoperative assessment

After surgery, an MRI is conducted to evaluate the presence and severity of any brain injury.

Additional assessments include cardiac function through echocardiography and brain function monitoring.

5 follow-up evaluations

At 3 months, general movements are assessed to evaluate neurodevelopmental outcomes.

At 24 months, further evaluations include the Bayley scales of infant development and executive functioning tests, as well as quality of life assessments using the TNO-TAPQOL questionnaire.

6 cost-effectiveness analysis

Throughout the hospital stay and at 3 and 24 months, questionnaires are used to assess the cost-effectiveness of allopurinol treatment.

7 pharmacokinetics study

A substudy is conducted to analyze the pharmacokinetics of allopurinol, focusing on how the drug is processed in the body postnatally and perioperatively.

Who Can Join the Study?

The patient must be a newborn baby.
The baby must have a serious heart condition present at birth, known as critical congenital heart disease. This means the heart has a problem that is present from birth and needs special care.
The heart condition must require surgery within the first 4 weeks of the baby’s life. This surgery involves using a machine called a cardiopulmonary bypass, which helps the heart and lungs work during the operation.
The heart condition can be diagnosed either before the baby is born (prenatally) or after birth (postnatally).
Both male and female newborns can participate in the study.

Who Cannot Join the Study?

Newborns who do not have critical congenital heart disease. This means the baby must have a serious heart condition present at birth that requires surgery.
Newborns who do not need cardiac surgery with cardiopulmonary bypass. This is a type of surgery where a machine temporarily takes over the function of the heart and lungs during the operation.
Newborns who are not at risk of brain injury related to their heart condition. The study focuses on babies who might have brain injuries due to their heart problems.
Newborns who are not in the age range specified for the study. The study is for a specific age group of newborns.
Newborns who are not part of the vulnerable population selected for the study. This means the study is looking at a specific group of babies who are considered at higher risk.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Uyinlblfokuu Mdtovom Ctfiodb Ghytdfbev	Groningen	The Netherlands
Etmwgvv Uthqrsxlcivw Mkripph Chsaqsq Rxjuzqnkj (xozdveh Mta	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	31.07.2024

Trial locations

Investigated drugs:

Allopurinol Sodium

Allopurinol is a medication being studied for its potential to protect the brain and heart in newborns with critical congenital heart disease who require cardiac surgery. The trial is investigating whether giving allopurinol shortly after birth and around the time of surgery can reduce significant brain injury, as seen on MRI scans after the operation.

Investigated diseases:

Brain injury

Brain Injury in Neonates with Critical Congenital Heart Disease – This condition occurs in newborns who have severe heart defects that require surgery involving a heart-lung machine. The brain injury can happen due to reduced blood flow or oxygen to the brain during or after the surgery. It may lead to damage in the brain tissue, which can be seen on imaging tests like MRI. The severity of the injury can vary, with some cases being moderate and others severe. This condition can affect brain function, including patterns of brain activity and the occurrence of seizures. Monitoring and assessment of brain oxygen levels and heart function are important aspects of understanding the progression of this condition.

Trial ID:

2024-513041-37-00

Protocol code:

18-791

NCT ID:

NCT04217421

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Allopurinol Sodium for Brain Injury Prevention in Newborns with Critical Congenital Heart Disease Undergoing Heart Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?