Therapeutic Hypothermia for Neonatal Encephalopathy
(TIME Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Sonia Bonifacio, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
The TIME Study is for newborns with Mild Hypoxic-Ischemic Encephalopathy, born at or after 36 weeks of pregnancy. They must show signs consistent with an acute event around birth and require resuscitation efforts at 10 minutes old. Babies with genetic issues, born before 36 weeks, weighing less than 1800 grams, or having moderate/severe HIE are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Therapeutic hypothermia or normothermia is applied for 72 hours using a servo-controlled temperature regulating blanket
Initial Hospital Stay
Participants are monitored for various health outcomes, including seizures, feeding initiation, and length of hospital stay
Follow-up
Neurodevelopmental outcome is assessed at 12-14 months of age using WIDEA-FS and AIMS
Long-term Follow-up
Developmental outcome is tracked at 2 years of age for all enrolled patients
What Are the Treatments Tested in This Trial?
Interventions
- Normothermia
- Therapeutic Hypothermia
Therapeutic Hypothermia is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Thrasher Research Fund
Collaborator