Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)
Condition: Diabetes in Pregnancy; Diabetes, Gestational; Infant, Newborn, Diseases; Perinatal Disorders of Growth and Development
MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Infant, Newborn, Diseases; Diabetes Mellitus
Study type: Observational

Summary: 
      Alterations in the intrauterine environment can have profound effects on fetal development.
      Diabetes during gestation results in multiple deleterious short-term outcome differences, and
      is correlated with long-term developmental deficits. Multiple studies, in neonates through
      school-aged children, have demonstrated differences in language, attention and psychomotor
      development in offspring of diabetic pregnancies. Neonatal EEG is a promising and
      non-invasive tool for assessment of abnormal brain development or "dysmaturity" in this
      population. Multiple conventional EEG (cEEG) and amplitude-integrated EEG (aEEG) parameters
      change predictably with advancing gestational development and have been used to differentiate
      between at risk groups in neonatal studies.

      The investigators hypothesize that neonatal EEG can identify brain dysmaturity in infants of
      diabetic mothers (IDMs) compared to gestational-age matched controls. The primary aim is
      documentation of brain dysmaturity in IDMs using cEEG. The secondary aim is establishment of
      aEEG as a more accessible tool to quantify the effects of maternal diabetes on neonatal brain
      development.

      The investigators will conduct a pilot study comparing cEEG and aEEG parameters of cases to
      gestational-age matched controls. Cases will be IDM neonates of at least 35 weeks' gestation
      whose mothers were recommended treatment with either insulin or an oral glycemic agent. Video
      EEG recording will be planned for approximately 60 minutes and obtained between 24 hours and
      5 days of life during birth hospitalization. Additional data will be extracted from maternal
      and neonatal medical records and a maternal questionnaire.

      In addition to evaluating the measures of cEEG and aEEG, this project will establish a
      research cohort. A subsequent study involving developmental evaluations will allow for
      correlation of EEG results with long-term outcomes. The ability to identify those at risk at
      birth would provide the opportunity to intervene in order to mitigate outcome differences,
      particularly in language development. More significantly, we hope to establish neonatal CNS
      outcome measures for future diabetic pregnancy intervention studies. .
    


Intervention name(s): Video Electroencephalogram (EEG); Point-of Care Blood Sugar Testing; Medical Record Data Extraction; Maternal Questionnaire
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Single neonatal video EEG at 24 hrs to 5 days of life during birth hospitalization. Neonatal scalp leads, respiratory and nasal leads. Approximately 60 minute recording.; One-time heel-stick point-of-care blood sugar testing at time of EEG.; Medical record data extraction from both maternal obstetric and neonatal medical record for variables known to impact EEG and neurodevelopmental outcomes.; One-time maternal questionnaire related to smoking practices, ETOH consumption, level of education, and body mass index.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be a convenience sample, comprised of singleton neonates born at
        or after 35 weeks post-menstrual age at the University of Rochester Medical Center (URMC).
        Cases will be infants of mothers with either a diagnoses of pre-gestational diabetes or
        gestational diabetes whose provider recommends treatment with insulin or oral glycemic
        agents. Controls will be neonates whose mothers had normal glucose testing during gestation
        and pre-pregnancy BMI of <30. All subjects will be otherwise healthy, as defined by the
        exclusion criteria. There is no intended racial, ethnic or gender distribution of these
        neonates.