Auswirkung von Allopurinol zusätzlich zur Standardbehandlung der Hypothermie bei reifgeborenen Kindern mit Sauerstoffmangel bei Geburt und Zeichen einer möglichen Hirnschädigung aufgrund Sauerstoffmangels während der Geburt.

Drug: Allopurinol;Drug: Mannitol

Gender: All
Maximum age: 45 Minutes
Minimum age: N/A

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