Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)

CompletedOBSERVATIONAL
Enrollment

39

Participants

Timeline

Start Date

September 1, 2016

Primary Completion Date

October 1, 2018

Study Completion Date

October 1, 2018

Conditions
Diabetes in PregnancyDiabetes, GestationalInfant, Newborn, DiseasesPerinatal Disorders of Growth and Development
Interventions
OTHER

Video Electroencephalogram (EEG)

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.

OTHER

Point-of Care Blood Sugar Testing

One-time heel-stick point-of-care blood sugar testing at time of EEG.

OTHER

Medical Record Data Extraction

Medical record data extraction from both maternal obstetric and neonatal medical record for variables known to impact EEG and neurodevelopmental outcomes.

OTHER

Maternal Questionnaire

One-time maternal questionnaire related to smoking practices, ETOH consumption, level of education, and body mass index.

Trial Locations (1)

14642

University of Rochester Medical Center, Rochester

All Listed Sponsors
lead

University of Rochester

OTHER

NCT02968628 - Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG) | Biotech Hunter | Biotech Hunter