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NCT01747863 · ClinicalTrials.gov registry record
Prospective Research in Infants With Mild Encephalopathy
A clinical trial, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre.
- Completed
- Registry status
- 63
- Enrollment target
NCT01747863: Completed study, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre.
NCT01747863 is a clinical trial that has completed, run by McGill University Health Centre/Research Institute of the McGill University Health Centre. The registered enrollment target is 63 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01747863 has completed, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre.
- COMPLETED
- Registry status
- 63 participants
- Enrollment target
Study 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.
Primary Outcome
Evidence of neurological dysfunction/injury/abnormality will be defined by any of these 3 criteria, as follows: 1. MRI = Brain MRI score of pattern of injury (NICHD-NRN) \> 0, 2. aEEG = abnormal background pattern on aEEG (voltage or background pattern) at 6 ± 3 hrs of age. 3. Any abnormality on the neurological at discharge exam.
Interventions
- OTHER Neurologic examination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2012-12 |
| Est. Completion | 2017-06 |
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre9 total trials
What the finished NCT01747863 record still lists
NCT01747863 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 63 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Neurologic examination is the first listed.
NCT01747863 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01747863 about?
NCT01747863 is a clinical study titled "Prospective Research in Infants With Mild Encephalopathy". 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 Sarn...
What is the current status of trial NCT01747863?
This trial is currently completed. The enrollment target is 63 participants. The study started on 2012-12. Estimated completion is 2017-06.
What interventions are being tested in trial NCT01747863?
The interventions under investigation include: Neurologic examination (OTHER).
Who is sponsoring clinical trial NCT01747863?
This trial is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre, which has 9 total clinical trials registered on ClinicalTrials.gov.
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