TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy (TIME)
Hypoxic-Ischemic Encephalopathy Mild, Neonatal Encephalopathy
About this trial
This is an interventional treatment trial for Hypoxic-Ischemic Encephalopathy Mild
Eligibility Criteria
Inclusion Criteria (must meet all 3):
- Neonates born at ≥ 36 0/7 weeks
Neonatal signs or contributing factors consistent with an acute peri-partum or intra-partum event (must meet a or b):
- pH ≤ 7.0 or Base deficit ≥ 16 in any umbilical cord or baby specimen at ≤ 1 hr of age OR
No umbilical cord or baby blood gas at ≤ 1 hr of age OR pH 7.01-7.15 or Base deficit 10-15.9 in any cord or baby specimen at ≤ 1 hr of age AND at least one of the following
- Apgar score at 10 min ≤ 5
- Continued need for resuscitation at 10 min (chest compressions, bag mask ventilation, intubation with positive pressure ventilation)
- Acute Perinatal Event: uterine rupture, placental abruption, cord accident (prolapse, rupture, knot or tight nuchal cord), maternal trauma, maternal hemorrhage or cardiorespiratory arrest, fetal exsanguination from either vasa previa or feto-maternal hemorrhage
- Fetal heart rate monitor pattern consistent with acute peripartum or intrapartum event (category III trace: no heart rate variability, presence of recurrent late or variable decelerations, bradycardia, or sinusoidal pattern)
Evidence of Mild Encephalopathy on Modified Sarnat Exam.
- Presence of at least 2 signs of mild, moderate or severe encephalopathy with no more than 2 moderate or severe findings in the 6 tested categories (level of consciousness, spontaneous activity, posture, tone, neonatal reflexes (suck and moro), and autonomic nervous system
Exclusion Criteria:
- Patients < 36 0/7 weeks birthweight < 1800gm; congenital or chromosomal anomaly associated with abnormal neurodevelopment or death; patients with moderate or severe HIE (by Sarnat exam or presence of clinical or electrographic seizures) identified within 6 hours after birth; core body temperature < 34°C for more than 1 hour prior to randomization.
Sites / Locations
- Loma Linda Children's Hospital
- Benioff Children's Hospital Oakland
- Children's Hospital Orange County
- Stanford University
- Rady Children's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Therapeutic Hypothermia
Normothermia
Therapeutic hypothermia will be achieved using a servo-controlled temperature regulating blanket that is approved for use in neonates and is currently used for the treatment of neonates with moderate-severe HIE. The goal target temperature is 33.5°C ± 0.5°C for 72 hours and the subject will then be rewarmed at a rate of 0.5°C per hour to a goal of 36.5°C.
Normothermia will be achieved using a servo-controlled temperature regulating blanket with the temperature goal of 36.5-37.3°C for 72 hours.