TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy

Not Recruiting

Trial ID: NCT04176471


The TIME study is a randomized, controlled trial to evaluate impact on early measures of neurodevelopment and the safety profile of therapeutic hypothermia in term neonates with Mild Hypoxic-Ischemic Encephalopathy who are < 6 hours of age. Neurodevelopmental outcome will be assessed at 12-14 months of age. The study will enroll 68 neonates randomized to therapeutic hypothermia or normothermia across 5 centers in California.

Official Title

The TIME STUDY: A Randomized Controlled Trial of Therapeutic Hypothermia for Infants With Mild Encephalopathy in California

Stanford Investigator(s)


Inclusion Criteria (must meet all 3):

   1. Neonates born at ≥ 36 0/7 weeks

   2. Neonatal signs or contributing factors consistent with an acute peri-partum or
   intra-partum event (must meet a or b):

      1. pH ≤ 7.0 or Base deficit ≥ 16 in any umbilical cord or baby specimen at ≤ 1 hr of
      age OR

      2. 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

   3. 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


other: Therapeutic Hypothermia

other: Normothermia

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sonia Bonifacio, MD