NCT02071394.
| Trial name or title | Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth: A Randomised Pilot Outcomes Study (CoolXenon3 Study) |
| Methods | Randomised controlled pilot outcomes study at 2 centres in the 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 < 8 cm H2O and fraction of inspired oxygen (FiO2) < 0.40, seizures under control, < 5 hours old, with birthweight greater than the second percentile for age, with no major congenital anomalies, and haemodynamically stable Excludes: infants older than 3 hours of age when cooling started, 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: death and moderate or severe disability (Bayley III) at 18 months of age Secondary outcomes: brain MRI within 2 weeks of birth and before hospital discharge, amplitude‐integrated electroencephalogram (aEEG) grading within 1 week of birth, number of hours after birth when aEEG voltage has reached a normal or discontinuous normal pattern, Dubovitz score within 7 days, number of normal infants (Bayley III composite score ≥ 85 and no neurosensory disability) at 18 to 24 months of age |
| Starting date | March 2014 |
| Contact information | Marianne Thoresen, MD |
| Notes | NCT02071394 |
aEEG: amplitude‐integrated electroencephalogram.
CO2: carbon dioxide.
FiO2: fraction of inspired oxygen.
MRI: magnetic resonance imaging.
pCO2: partial pressure of CO2.