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Clinical Trials/NCT02968628
NCT02968628
Completed
Not Applicable

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

University of Rochester1 site in 1 country39 target enrollmentSeptember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes in Pregnancy
Sponsor
University of Rochester
Enrollment
39
Locations
1
Primary Endpoint
Maximum Interburst Interval on cEEG
Status
Completed
Last Updated
6 years ago

Overview

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. .

Registry
clinicaltrials.gov
Start Date
September 1, 2016
End Date
October 1, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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 Exclusion Criteria:
  • Diagnosis by obstetrician of intrauterine growth restriction (IUGR)
  • Documentation in medical record of daily maternal cigarette smoking during 2nd or 3rd trimester
  • Chronic maternal sedative or opiate use (\>weekly use)
  • Recreational opiate use or addiction
  • Cocaine or amphetamine use during pregnancy
  • ETOH abuse or concern for abuse during pregnancy (\>weekly use)
  • Other maternal conditions that may compromise fetus
  • Psychiatric medications beyond isolated SSRI use
  • Anti-epileptic drugs (AEDs) during gestation

Outcomes

Primary Outcomes

Maximum Interburst Interval on cEEG

Time Frame: Single EEG between 24 hours of life and 5 days of life

Lower Margin Amplitude on aEEG

Time Frame: Single EEG between 24 hours of life and 5 days of life

Secondary Outcomes

  • Number of Delta Brushes on cEEG(Single EEG between 24 hours of life and 5 days of life)
  • Bandwidth on aEEG(Single EEG between 24 hours of life and 5 days of life)

Study Sites (1)

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