Prospective Research in Infants With Mild Encephalopathy
Completed
Conditions studied: Hypoxic-Ischemic Encephalopathy, Brain Injury, Neonatal Seizure
In brief
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.
Key facts
- Study ID
- NCT01747863
- Run by
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- People needed
- 63
- Starts
- 2012-12-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2025-01-28
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants with birth weight > or = 1800g and gestational age > or = 36 weeks AND
- Admission to neonatal intensive care unit (NICU) for possible hypothermia at < or = 6hr of life
You may not qualify if…
- Infants with normal neurological evaluation
- Major congenital abnormalities
- Refusal of informed consent
- Infants who receive passive or active cooling prior to the NICU admission
- Infants that develop seizures or moderate/severe NE within the first 24 hr of life and are initiated on therapeutic hypothermia after 6 hr of life.
Where it is running
- Wayne State University — Detroit, Michigan, United States
- The Ohio Stage University - Nationwide Children's Hospital — Columbus, Ohio, United States
- Brown University — Providence, Rhode Island, United States
- University of Texas Southwestern — Dallas, Texas, United States
- Montreal Children's Hospital — Montreal, Quebec, Canada
- Mahidol University - Ramathibodi Hospital — Bangkok, Thailand
- Imperial College London — London, United Kingdom
Full record on ClinicalTrials.gov
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