Education and Training

TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy

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.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • other: Therapeutic Hypothermia
  • other: Normothermia

Eligibility


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
         pattern)

   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
   randomization.

Ages Eligible for Study

N/A - 6 Hours

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sonia Bonifacio, MD
Not Recruiting