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Allopurinol Sodium

Clinical trials of Allopurinol Sodium are studying whether it can improve outcomes in newborns at high risk of brain injury. The trials are looking at safety and effectiveness in babies with hypoxic-ischemic encephalopathy and in newborns with critical congenital heart disease needing surgery.

Table of contents

Overview of the clinical research

The available trials of Allopurinol Sodium are studying newborns who are at high risk of brain injury.[1][2] Both studies are Phase 3, which means they are later-stage trials designed to test how well the treatment works in a larger group of patients.[1][2] Both are also interventional, meaning the researchers give a treatment and compare outcomes with another group.[1][2]

Trial in newborns with hypoxic-ischemic encephalopathy

NCT03162653 is a Phase 3 interventional trial in newborns with asphyxia and early clinical signs of hypoxic-ischemic encephalopathy (HIE), a brain injury caused by low oxygen and poor blood flow around birth.[1] The trial is authorised and includes 503 participants.[1]

The study is testing whether early postnatal Allopurinol Sodium, given in addition to standard care and therapeutic hypothermia if needed, can reduce the risk of death or severe neurodevelopmental impairment at 24 months of age.[1] Severe neurodevelopmental impairment in this trial includes cerebral palsy, or cognitive or language problems defined by Bayley Scales scores below 85.[1]

Trial in newborns with critical congenital heart disease

NCT04217421 is another Phase 3 interventional trial, also authorised, with 236 participants.[2] It studies newborns with critical congenital heart disease who need cardiac surgery with cardiopulmonary bypass, a machine-assisted method used during heart surgery.[2]

This study is examining whether early postnatal and perioperative Allopurinol Sodium, given around the time of surgery, can reduce relevant brain injury after surgery.[2] The comparison is against placebo mannitol, and the main focus is brain injury seen on postoperative MRI.[2]

What the trials measure

The first trial measures a combined outcome at age two years: death, severe neurodevelopmental impairment, or survival without severe impairment.[1] A combined outcome means the study counts more than one important result together, so researchers can better understand the overall effect on children.[1]

The second trial uses a composite endpoint, which means it combines several results into one main measure.[2] That endpoint includes moderate or severe brain injury on MRI, being too unstable to have the MRI, or death.[2]

Who the trials are for

These studies are focused on newborns, not older children or adults.[1][2] One group includes babies with birth-related oxygen shortage and early signs of brain injury, while the other includes babies with serious heart disease who need surgery soon after birth.[1][2] In both trials, the goal is to protect the brain during a very vulnerable time in early life.[1][2]

Important terms explained

  • Authorised means the trial has been approved to go ahead.[1][2]

  • Placebo means a treatment that looks like the study treatment but does not contain the active study drug.[1][2]

  • Standard of care means the usual treatment given to patients outside the study drug.[1]

  • Postoperative MRI means an MRI scan done after surgery to check for brain injury.[2]

  • Neurodevelopmental impairment means problems with a child’s development, such as movement, learning, or language.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT03162653Phase 3Hypoxic-ischemic encephalopathy after birth asphyxiaAuthorised503
NCT04217421Phase 3Brain injury in neonates with critical congenital heart disease needing cardiac surgeryAuthorised236

FAQ

  • What are the clinical trials of Allopurinol Sodium studying? They are studying whether Allopurinol Sodium can reduce brain injury and improve long-term outcomes in newborns. The main goals are to lower death, severe developmental problems, and brain damage seen on scans.
  • Who can take part in these trials? The trials focus on newborns. One trial includes babies with asphyxia and early signs of hypoxic-ischemic encephalopathy, and the other includes newborns with critical congenital heart disease who need heart surgery with cardiopulmonary bypass.
  • What phases are the trials in? Both trials are Phase 3 studies. This means they are later-stage trials that test how well the treatment works in a larger group of patients.
  • What conditions are being studied? One trial studies hypoxic-ischemic encephalopathy, a type of brain injury caused by low oxygen around birth. The other studies brain injury in newborns with critical congenital heart disease who need surgery.
  • What outcomes are the trials measuring? One trial measures death, severe neurodevelopmental impairment, or survival without severe impairment at age two years. The other measures moderate or severe brain injury on postoperative MRI, being too unstable for MRI, or death.

Sperimentazioni cliniche in corso su Allopurinol Sodium

  • Studio sull’uso di allopurinolo per proteggere il cervello nei neonati con cardiopatia congenita critica

    In arruolamento

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Paesi Bassi

  • Studio sull’effetto dell’allopurinolo e ipotermia per l’encefalopatia ipossico-ischemica nei neonati

    Arruolamento concluso

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Austria Belgio Estonia Finlandia Germania Italia +3

Glossario

  • Clinical trial: A planned research study in people. It is used to see whether a treatment is safe and whether it works.
  • Interventional study: A study where researchers give a treatment and then compare results with another group.
  • Phase 3: A later stage of research with more participants. It helps show how well a treatment works and confirms earlier findings.
  • Hypoxic-ischemic encephalopathy (HIE): Brain injury that happens when a baby does not get enough oxygen and blood flow around birth.
  • Asphyxia: A serious lack of oxygen during or around birth.
  • Therapeutic hypothermia: A treatment that lowers body temperature to help protect the brain after oxygen-related injury.
  • Critical congenital heart disease: A serious heart problem that is present at birth and often needs surgery.
  • Cardiopulmonary bypass: A machine-assisted technique used during heart surgery to take over the work of the heart and lungs for a time.
  • MRI: A scan that uses magnets and radio waves to make detailed pictures of the body, including the brain.
  • Neurodevelopmental impairment: Problems with brain development that can affect movement, learning, speech, or thinking.

Riferimenti

  1. https://studi-clinici.it/studio/studio-sulleffetto-dellallopurinolo-e-ipotermia-per-lencefalopatia-ipossico-ischemica-nei-neonati/
  2. https://studi-clinici.it/studio/studio-sulluso-di-allopurinolo-per-proteggere-il-cervello-nei-neonati-con-cardiopatia-congenita-critica/