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TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy

United States68 participantsStarted 2020-05-01

Plain-language summary

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 can participate

Age range

6 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Neonates born at ≥ 36 0/7 weeks
. Neonatal signs or contributing factors consistent with an acute peri-partum or intra-partum event (must meet a or b):
. pH ≤ 7.0 or Base deficit ≥ 16 in any umbilical cord or baby specimen at ≤ 1 hr of age OR
. 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
. Evidence of Mild Encephalopathy on Modified Sarnat Exam.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)

Timeframe: Assessment takes up to 15 minutes and will be conducted at 12-14 months of age

Alberta Infant Motors Scale (AIMS)

Timeframe: Assessment takes up to 15 minutes and will be conducted at 12-14 months of age

Trial details

NCT IDNCT04176471

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-31

Contact for this trial

Sonia L Bonifacio, MD

650-723-5711 soniab1@stanford.edu

View on ClinicalTrials.gov More Hypoxic-Ischemic Encephalopathy Mild trials