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Telemedicine to Reduce Disparities in the Identification and Treatment of Neonatal Encephalopathy

NCT05155111 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-01-05

No results posted yet for this 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.

Conditions

  • Neonatal Encephalopathy

Interventions

DIAGNOSTIC_TEST

Telemedicine consult

A joint assessment between Neonatologist at bedside and Neurologist by telemedicine will be performed to assess severity of neonatal encephalopathy

Sponsors & Collaborators

  • MaineHealth

    lead OTHER

Principal Investigators

  • Alexa K Craig, MD · physician

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Hours
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-22
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05155111 on ClinicalTrials.gov