Therapeutic Hypothermia for Neonatal Encephalopathy

(TIME Trial)

Recruiting at 4 trial locations

Overseen By Krisa Van Meurs, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Preterm birth, Low birthweight, Anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 72 hours

68 Participants Needed

Trial Summary

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.

Research Team

Sonia Bonifacio, MD

Principal Investigator

Stanford University

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Therapeutic Hypothermia Experimental Treatment 1 Intervention

Therapeutic hypothermia will be achieved using a servo-controlled temperature regulating blanket that is approved for use in neonates and is currently used for the treatment of neonates with moderate-severe HIE. The goal target temperature is 33.5°C ± 0.5°C for 72 hours and the subject will then be rewarmed at a rate of 0.5°C per hour to a goal of 36.5°C.

Group II: Normothermia Active Control 1 Intervention

Normothermia will be achieved using a servo-controlled temperature regulating blanket with the temperature goal of 36.5-37.3°C for 72 hours.

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

Approved in United States as Therapeutic Hypothermia for:

• Cardiac arrest in adults and children
• Birth asphyxia in newborns

Approved in European Union as Therapeutic Hypothermia for:

• Cardiac arrest in adults and children
• Birth asphyxia in newborns

Approved in Canada as Therapeutic Hypothermia for:

• Cardiac arrest in adults and children
• Birth asphyxia in newborns

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+