68 Participants Needed

Therapeutic Hypothermia for Neonatal Encephalopathy

(TIME Trial)

Recruiting at 4 trial locations
SL
KV
Overseen ByKrisa Van Meurs, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

SB

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

The baby's heart rate pattern shows signs of distress during labor or delivery.
My baby was born at or after 36 weeks of pregnancy.
My newborn shows signs of distress from birth complications.
See 5 more

Exclusion Criteria

Your body temperature has been lower than 34°C for more than 1 hour before the study starts.
I have a genetic condition affecting my brain development or causing risk of death.
Patients who are less than 36 weeks pregnant.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

First 24 hours of life

Treatment

Therapeutic hypothermia or normothermia is applied for 72 hours using a servo-controlled temperature regulating blanket

72 hours

Initial Hospital Stay

Participants are monitored for various health outcomes, including seizures, feeding initiation, and length of hospital stay

Up to 30 days

Follow-up

Neurodevelopmental outcome is assessed at 12-14 months of age using WIDEA-FS and AIMS

12-14 months

Long-term Follow-up

Developmental outcome is tracked at 2 years of age for all enrolled patients

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Normothermia
  • Therapeutic Hypothermia
Trial Overview This study tests the effects of cooling therapy (therapeutic hypothermia) versus normal temperature maintenance (normothermia) on brain health in term neonates with mild brain injury due to oxygen deprivation. Outcomes will be measured by neurodevelopmental progress at about one year old.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Therapeutic HypothermiaExperimental Treatment1 Intervention
Group II: NormothermiaActive Control1 Intervention

Therapeutic Hypothermia is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Therapeutic Hypothermia for:
🇪🇺
Approved in European Union as Therapeutic Hypothermia for:
🇨🇦
Approved in Canada as Therapeutic Hypothermia for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Thrasher Research Fund

Collaborator

Trials
135
Recruited
96,600+
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