Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome

Launched by UNIVERSITY HOSPITAL TUEBINGEN · May 19, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called allopurinol on newborns who have experienced a serious condition known as hypoxic-ischemic encephalopathy (HIE). HIE can occur when an infant’s brain is not getting enough oxygen during labor and delivery, which can lead to long-term health issues or even death. The trial aims to see if giving allopurinol to infants right after birth, in addition to the standard treatment of hypothermia (cooling the body to protect the brain), can help improve their brain function and overall health outcomes.

To be eligible for this study, infants must be born at term or near-term and show signs of HIE, such as needing resuscitation or having abnormal blood tests related to oxygen levels. The trial is open to all newborns that meet these criteria, and parents will be fully informed about what their child can expect during the study. This includes monitoring and care while receiving the medication alongside the usual treatments. It's important to note that not all newborns will be suitable for participation, and there are specific reasons, such as being too premature or having serious health concerns, that may exclude them from the trial.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• Term and near-term infants with a history of disturbed labour who meet at least one criterion of perinatal acidosis (or ongoing resuscitation) and at least two early clinical signs of potentially evolving encephalopathy as defined herein:
• Severe perinatal metabolic acidosis or ongoing cardiopulmonary resuscitation at 5 min after birth:
• • At least 1 out of the following 5 criteria must be met
• • Umbilical (or arterial or reliable venous) blood gas within 30 min after birth with pH\<7.0
• • Umbilical (or arterial or reliable venous) blood gas within 30 min after birth with base deficit ≥16 mmol/l
• • Need for ongoing cardiac massage at/beyond 5 min postnatally
• • Need for adrenalin administration during resuscitation
• • APGAR score ≤5 at 10min AND
• Early clinical signs of potentially evolving encephalopathy:
• At least 2 out of the following 4 criteria must be met:
• • Altered state of consciousness (reduced or absent response to stimulation or hyperexcitability)
• • Severe muscular hypotonia or hypertonia,
• • Absent or insufficient spontaneous respiration (e.g., gasping only) with need for respiratory support at 10 min postnatally
• • Abnormal primitive reflexes (absent suck or gag or corneal or Moro reflex) or abnormal movements (e.g., potential clinical correlates of seizure activity)
• • Exclusion criteria
• • gestational age below 36 weeks
• • birth weight below 2500 g
• • postnatal age \>30min at the end of screening phase
• • severe congenital malformation or syndrome requiring neonatal surgery or affecting long-term outcome
• • patient considered "moribund" / "non-viable" (e.g., lack of spontaneous cardiac activity and ongoing chest compression at 30min)
• • decision for "comfort care only" before study drug administration
• • parents declined study participation as response to measures of community engagement
• • both parents are insufficiently fluent in the study site's national language(s) or English or do not seem to have the intellectual capacity to understand the study procedures and to give consent as judged by the personnel who had been in contact with the mother/father before delivery.
• • both parents/guardians less than 18 years of age, in case of single parent/guardian this one less than 18 years of age