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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 range6 Hours

SexALL

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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.

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