TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy

Status unconfirmed · Not applicable

Conditions studied: Hypoxic-Ischemic Encephalopathy Mild, Neonatal Encephalopathy

In brief

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.

Key facts

Study ID

NCT04176471

Run by

Stanford University

People needed

68

Starts

2020-05-01

Expected to finish

2025-01-31

Last updated by the study team

2020-03-18

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Loma Linda Children's Hospital — Loma Linda, California, United States
• Benioff Children's Hospital Oakland — Oakland, California, United States
• Children's Hospital Orange County — Orange, California, United States
• Stanford University — Palo Alto, California, United States
• Rady Children's Hospital — San Diego, California, United States

Full record on ClinicalTrials.gov

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