Diabetes, Gestational Clinical Trial
Official title:
Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)
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. .
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