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NCT05155111 · ClinicalTrials.gov registry record · NA
Telemedicine to Reduce Disparities in the Identification and Treatment of Neonatal Encephalopathy
A NA study, sponsored by MaineHealth.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT05155111: Completed NA study, sponsored by MaineHealth.
NCT05155111 is a NA study that has completed, run by MaineHealth. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05155111, a NA study, has completed, sponsored by MaineHealth.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is a clinical trial using telemedicine as an intervention twice in the first 6 hours of life to assess neonatal encephalopathy, one of the key factors involved in the decision to treat a neonate with therapeutic hypothermia (TH). The investigators aim to enroll up to 30 neonates, anticipating that there will be about 5 neonates, who do not demonstrate moderate to severe neonatal encephalopathy, and therefore do not meet criteria for treatment with TH. The investigators will prospectively follow the clinical course of all 30neonates through monitoring with electroencephalogram (EEG) for up to 24 hours after birth to determine if seizures are present and by MRI of the brain prior to hospital discharge to determine if there is evidence of brain injury. Neonates will be enrolled in the study for the duration of their hospital admission.
Primary Outcome
The primary outcome is a combined outcome. This will include the presence of absence of seizure activity on the electroencephalogram (EEG) during the first 24 hours of life and/or the presence or absence of injury to the brain detected on magnetic resonance imaging of the brain (MRI) performed prior to hospital discharge.
Interventions
- DIAGNOSTIC_TEST Telemedicine consult
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-12-22 |
| Est. Completion | 2023-12-31 |
| Phase | NA |
What the finished NCT05155111 record still lists
NCT05155111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Telemedicine consult is the first listed.
NCT05155111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05155111 about?
NCT05155111 is a clinical study titled "Telemedicine to Reduce Disparities in the Identification and Treatment of Neonatal Encephalopathy". This is a clinical trial using telemedicine as an intervention twice in the first 6 hours of life to assess neonatal encephalopathy, one of the key factors involved in the decision to treat a neonate with therapeutic hypothermia (TH). The investigators aim to enroll up to 30 neonates, anticipating t...
What is the current status of trial NCT05155111?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2021-12-22. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT05155111?
The interventions under investigation include: Telemedicine consult (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05155111?
This trial is sponsored by MaineHealth, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05155111's enrollment target sits among peer trials
23 1755th of 2000 higher than 245 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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