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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 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.
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.
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
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01747863
The ClinicalTrials.gov registry entry for NCT01747863 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is McGill University Health Centre/Research Institute of the McGill University Health Centre, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Neurologic examination is the first listed.
NCT01747863 reports 0 study locations.
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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