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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05155111
Recruitment Status : Recruiting
First Posted : December 13, 2021
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
Alexa Craig, MaineHealth

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 150 neonates, anticipating that there will be about 100 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.

Condition or disease Intervention/treatment Phase
Neonatal Encephalopathy Diagnostic Test: Telemedicine consult Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Telemedicine for Identification of Neonatal Encephalopathy
Actual Study Start Date : December 22, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

Arm Intervention/treatment
Experimental: Telemedicine arm
Neonates will have telemedicine consultation to evaluate symptoms of neonatal encephalopathy
Diagnostic Test: Telemedicine consult
A joint assessment between Neonatologist at bedside and Neurologist by telemedicine will be performed to assess severity of neonatal encephalopathy




Primary Outcome Measures :
  1. Combined outcome of seizure or brain Injury on imaging [ Time Frame: First 10 days of life ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   0 Hours to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05155111


Contacts
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Contact: Alexa K Craig, MD 2078831414 craiga@mmc.org

Locations
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United States, Maine
Northern Light Eastern Maine Medical Center Not yet recruiting
Bangor, Maine, United States, 04401
Contact: Jay Kerecman, MD    207-275-1082    jkerecman@northernlight.org   
Principal Investigator: Jay Kerecman, MD         
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Alexa Craig, MD    207-883-1414    craiga@mmc.org   
Principal Investigator: Alexa Craig, MD         
Sub-Investigator: Misty Melendi, MD         
United States, Vermont
University of Vermont Medical Center Not yet recruiting
Burlington, Vermont, United States, 05401
Contact: Deirdre O'Reilley, MD    802-847-2100    Deirdre.O'Reilly@uvmhealth.org   
Principal Investigator: Deirdre O'Reilly', MD         
Sponsors and Collaborators
MaineHealth
Investigators
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Principal Investigator: Alexa K Craig, MD physician
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Responsible Party: Alexa Craig, Attending Neonatal and Pediatric Neurologist, MaineHealth
ClinicalTrials.gov Identifier: NCT05155111    
Other Study ID Numbers: 1781443
First Posted: December 13, 2021    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexa Craig, MaineHealth:
Telemedicine
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases