A Randomized Trial of Targeted Temperature Management With Whole Body Hypothermia For Moderate And Severe Hypoxic-Ischemic Encephalopathy In Premature Infants 33-35 Weeks Gestational Age.

Fecha de inicio: 1 de mayo de 2015

Inclusion Criteria: Infants 33 0/7 to 35 6/7 weeks GA (best obstetrical estimate) Infants weight greater than or equal to 1500 grams at birth Postnatal age less than 6 hours Infants who meet clinical, biochemical and neurologic criteria for moderate to severe NE: Biochemical: Cord gas or blood gas within first hour of life with pH ≤7.00 or base deficit (BD) ≥16 mEq/L OR Acute perinatal event (e.g., abruptio placenta, cord prolapse, uterine rupture, severe FHR abnormality such as variable or late decelerations) AND Requirement for positive pressure ventilation for apnea or poor respiratory effort since birth for at least 10 minutes OR 10 minute Apgar score ≤5 AND Neurologic: Seizures OR modified Sarnat score with abnormalities in at least 3 of the 6 categories; at least one must be altered level of consciousness (lethargy or stupor/coma) as determined by a certified examiner (All infants who meet criteria for potential inclusion will undergo standard neurologic exam as for infants ≥36 wks GA being considered for hypothermia, with findings recorded) Exclusion Criteria: Receipt of sedative, analgesic or paralytic agent that may confound the qualifying neurologic exam Etiology of NE not likely to be hypoxic-ischemic in origin Major congenital anomaly that may confound outcome Considered to be moribund and will not be receiving full intensive care Equipment and/or appropriate staff not available Core temperature < 33.5oC for more than one hour at time of screening Unable to randomize by 6 hours of age Infant needs ECMO All blood gases (cord and postnatal at < 1hr of age) have a pH > 7.15 AND a base deficit < 10mEq/L