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