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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02968628
Enrollment
39
Registered
2016-11-18
Start date
2016-09-01
Completion date
2018-10-01
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gestational, Diabetes in Pregnancy, Infant, Newborn, Diseases, Perinatal Disorders of Growth and Development

Brief 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. .

Interventions

OTHERVideo 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.

OTHERPoint-of Care Blood Sugar Testing

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

OTHERMedical Record Data Extraction

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

OTHERMaternal Questionnaire

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

Sponsors

University of Rochester
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
24 Hours to 120 Hours
Healthy volunteers
Yes

Inclusion criteria

* \>/= 35 weeks post-menstrual age at delivery * Dating by, or consistent with, 1st trimester ultrasound * Mother able to communicate in oral and written English * Available maternal obstetric record and medication history * Singleton gestation * Delivery at URMC attended by obstetric staff

Exclusion criteria

Maternal

Design outcomes

Primary

MeasureTime frame
Maximum Interburst Interval on cEEGSingle EEG between 24 hours of life and 5 days of life
Lower Margin Amplitude on aEEGSingle EEG between 24 hours of life and 5 days of life

Secondary

MeasureTime frame
Number of Delta Brushes on cEEGSingle EEG between 24 hours of life and 5 days of life
Bandwidth on aEEGSingle EEG between 24 hours of life and 5 days of life

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026