Telemedicine to Reduce Disparities in the Identification and Treatment of Neonatal Encephalopathy
Primary Purpose
Neonatal Encephalopathy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine consult
Sponsored by
About this trial
This is an interventional diagnostic trial for Neonatal Encephalopathy focused on measuring Telemedicine
Eligibility Criteria
Inclusion Criteria:
- 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)
- 10-minute Apgar score < 5
- Need for respiratory support for >10 minutes not otherwise due to a primary pulmonary process
Exclusion Criteria:
- 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
Sites / Locations
- Maine Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Telemedicine arm
Arm Description
Neonates will have telemedicine consultation to evaluate symptoms of neonatal encephalopathy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05155111
Brief Title
Telemedicine to Reduce Disparities in the Identification and Treatment of Neonatal Encephalopathy
Official Title
Telemedicine for Identification of Neonatal Encephalopathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MaineHealth
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 150 neonates 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.
Detailed Description
Neonatal encephalopathy is a clinically defined condition of disturbed neurological function in an infant of greater than 35 weeks gestation. Neonatal encephalopathy is most likely to occur following a traumatic birth that requires some degree of neonatal resuscitation. Therapeutic hypothermia (TH) is the standard-of-care neuroprotective therapy employed for neonates who have symptoms of moderate to severe neonatal encephalopathy. Assessment of neonatal encephalopathy can be challenging because the symptoms can fluctuate and because there is time pressure to decide to initiate TH before the neonate is 6 hours old, after which TH has almost no beneficial effect. Doctors struggle with the decision to treat neonates with milder symptoms and these neonates are at risk for two possible adverse outcomes; 1) an eligible neonate is not recognized and therefore not treated with TH or 2) an ineligible neonate may receive unnecessary treatment. The first error is one that can result in lifelong impairments such as learning delays, epilepsy and cerebral palsy for the untreated child and the second error, of unnecessary treatment is costly, invasive and not without risk of associated issues with morphine exposure, cold-induced injury to the skin or complications from venous access such as infection or blood clot.
In Maine, the investigators have successfully implemented telemedicine both in the tertiary care center and in the rural community hospital to permit visual evaluation of neonates and inform joint decision making in these challenging instances. Telemedicine provides the opportunity to have synchronous, unscheduled immediate expert consultation for neonatologists with pediatric neurology in the tertiary care center and for primary care physicians with both specialists in the community hospital setting. The objective of the present study is to develop the telemedicine consultative network to continue to improve patient selection for TH. The investigators aim to use telemedicine consults in three tertiary care centers (Maine Medical Center, Northern Light Eastern Maine Medical Center and the University of Vermont Medical Center) to develop evidence for the threshold at which neonates can be safely excluded from TH treatment. In Aim 1, the investigators will assess neonates with milder symptoms at least twice in the first 6 hours of life and for those not meeting criteria for moderate or severe neonatal encephalopathy, perform electroencephalogram (EEG) to rule out seizures and MRI of the brain to rule out injury. In aim 2, the investigators will compare the interrater reliability between the neonatologist neonatal encephalopathy exam and the one performed via telemedicine by the pediatric neurologist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Encephalopathy
Keywords
Telemedicine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine arm
Arm Type
Experimental
Arm Description
Neonates will have telemedicine consultation to evaluate symptoms of neonatal encephalopathy
Intervention Type
Diagnostic Test
Intervention Name(s)
Telemedicine consult
Intervention Description
A joint assessment between Neonatologist at bedside and Neurologist by telemedicine will be performed to assess severity of neonatal encephalopathy
Primary Outcome Measure Information:
Title
Combined outcome of seizure or brain Injury on imaging
Description
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.
Time Frame
First 10 days of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Hours
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
10-minute Apgar score < 5
Need for respiratory support for >10 minutes not otherwise due to a primary pulmonary process
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexa K Craig, MD
Phone
2078831414
Email
craiga@mmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexa K Craig, MD
Organizational Affiliation
physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexa Craig, MD
Phone
207-883-1414
Email
craiga@mmc.org
First Name & Middle Initial & Last Name & Degree
Alexa Craig, MD
First Name & Middle Initial & Last Name & Degree
Misty Melendi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telemedicine to Reduce Disparities in the Identification and Treatment of Neonatal Encephalopathy
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