Telemedicine to Reduce Disparities in the Identification and Treatment of Neonatal Encephalopathy
Condition: Neonatal Encephalopathy
MeSH terms: Brain Diseases
Study type: Interventional

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.
    

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.
    

Intervention name(s): Telemedicine consult
Intervention type(s): Diagnostic Test
Intervention description(s): A joint assessment between Neonatologist at bedside and Neurologist by telemedicine will be performed to assess severity of neonatal encephalopathy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Telemedicine