NCT01545271.

Trial name or title	Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth: Randomised Pilot Study (The CoolXenon2 Study)
Methods	Randomised controlled single‐centre pilot study in UK
Participants	Includes: infants born at ≥ 36 weeks’ gestation WITH clinical evidence of peripartum hypoxia‐ischaemia (Apgar score ≤ 5 at 10 minutes, continued need for resuscitation at 10 minutes, or severe acidosis (pH < 7 or base deficit ≥ 16 mmol/L in cord blood or arterial/venous blood within 60 minutes of birth)) AND abnormal amplitude‐integrated electroencephalogram background AND moderate or severe encephalopathy (Sarnat criteria) with 1 of hypotonia, abnormal reflexes, absent or weak suck, clinical seizures, or a combination. For xenon therapy, infants must be intubated with normal partial pressure of CO2 (pCO2), positive end‐expiratory pressure < 6 cm H2O and fraction of inspired oxygen (FiO2) < 0.40, seizures under control, weighing > 2.3 kg and < 5 hours old, with birthweight greater than the second percentile for age, with no major congenital anomalies, and haemodynamically stable with no evidence of infection Excludes: infants considered futile and infants not meeting above criteria
Interventions	Standard care: cooling to 33.5°C body temperature, starting within 3 hours after birth Intervention: cooling to 33.5°C body temperature plus xenon gas at 50% concentration for 18 hours, started within 5 hours after birth
Outcomes	Primary outcomes: amplitude‐integrated electroencephalogram (aEEG) grading: number of hours after birth when aEEG voltage has reached normal or discontinuous normal pattern. Brain MRI findings before 2 weeks of age Secondary outcomes: not provided
Starting date	May 2012
Contact information	Marianne Thoresen, MD
Notes	NCT01545271