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

NCT05155111 | Completed

• 1 other identifier: 1781443
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Telemedicine

Outcome Measures

Primary Outcomes (1)

• Combined outcome of seizure or brain Injury on imaging

  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.

  First 10 days of life

Study Arms (1)

Telemedicine arm

EXPERIMENTAL

Neonates will have telemedicine consultation to evaluate symptoms of neonatal encephalopathy

Diagnostic Test: Telemedicine consult

Interventions

Telemedicine consult DIAGNOSTIC_TEST

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

Telemedicine arm

Eligibility Criteria

• Age: 0 Hours - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Umbilical cord pH ≤7.0 or base deficit ≥ -16
• Umbilical cord pH 7.01 to 7.15 or base deficit between -10 and -16 AND one of the following;
• a perinatal event, defined as severe fetal heart rate abnormality such as category 2 or 3 tracing with recurrent variable decelerations, prolonged decelerations or recurrent late decelerations, umbilical cord prolapse/rupture, uterine rupture, significant placental abruption, maternal trauma or hemorrhage or cardiopulmonary arrest)
• minute Apgar score \< 5
• Need for respiratory support for \>10 minutes not otherwise due to a primary pulmonary process

You may not qualify if:

• Older than 6 hours
• Gestational age less than or equal to 35 6/7 weeks
• Birthweight \<1800 grams
• Non-English speaking parents due to time constraints to perform the consent process

Sponsors & Collaborators

• MaineHealth: lead

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

Study Officials

• Alexa K Craig, MD

  physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Neonatal and Pediatric Neurologist

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 13, 2021
• Study Start: December 22, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)