CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Neurologic examinationother
Likely dose
Not stated in record
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NCT01747863N/ACompleted
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Prospective Research in Infants With Mild Encephalopathy: the PRIME Study.

McGill University Health Centre/Research Institute of the McGill University Health Centre·observational·Posted Dec 12, 2012·Updated Jan 28, 2025

In Brief

An observational study evaluating Neurologic examination for Hypoxic-Ischemic Encephalopathy and 2 related conditions. Completed, enrolled 63 participants across 7 sites in 4 countries.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHypoxic-Ischemic Encephalopathy, Brain Injury, Neonatal Seizure
CountriesCanada, Thailand, United Kingdom, United States
CollaboratorsBrown University, University of Texas Southwestern Medical Center, Wayne State University, Mahidol University, Ohio State University, Imperial College London

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 12, 2012
Enrollment StartDec 1, 2012
Primary CompletionDec 1, 2015
Study CompletionJun 1, 2017
TodayJul 1, 2026
Enrollment to primary: 3 yearsPosted 13.6 years ago

Interventions

Neurologic examinationother

Neurologic examination includes: (1) neurologic examination using modify Sarnat score at \</= 6 hrs of age, 24 hrs and at discharge home, (2) aEEG at 6 ± 3 hrs of age, (3) Brain MRI before discharge home to 30 days of age.