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More info
You can access this
clinical trial
if you have
Hypoxic-Ischemic Encephalopathy, Brain Injury or Neonatal Seizure
and you are
under 6
years old
-
This is an observational trial.
You are contributing to medical knowledge about your condition.
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The purpose

A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia. The intervention includes: neurologic examination by using modified Sarnat score at ≤ 6 hrs of age, 24 hrs and before discharge home, amplitude-integrated electroencephalography (aEEG) at 6 ± 3 hrs of age, brain MRI at before discharge home to 30 days of age and follow-up at 18-22 months of age. Primary outcome is the percentage of mild NE infants with evidence of brain injury defined by the presence of at least 1 abnormality of brain MRI, aEEG or neurologic examination in the neonatal period. Secondary outcome is the percentage of brain MRI, aEEG and neurological exam abnormalities, seizure, length of hospital stay, need of gavage feeds or gastrostomy at discharge home, death and long-term outcome.

Provided treatments

  • Other: Neurologic examination

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01747863. The sponsor of the trial is McGill University Health Center and it is looking for 63 volunteers for the current phase.
Official trial title:
Prospective Research in Infants With Mild Encephalopathy: the PRIME Study.