Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/28/2019 |
| Start Date: | September 1, 2016 |
| End Date: | December 31, 2020 |
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. .
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. .
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
- Magnesium exposure within 3 days of delivery
Neonatal Exclusion Criteria:
- Blood gas pH of less than 7.1, if obtained (cord or any prior to EEG)
- Apgar less than 8 at 5 min
- CNS malformations, seizures, subgaleal or intracranial bleeds
- Cardiac anomalies except asymptomatic small-moderate VSD, ASD, or PDA
- Clinically significant malformations or chromosomal anomalies
- Small-for-gestational age (<10th % on Fenton growth curve)
- Respiratory distress ever requiring intubation or requiring CPAP support > 48 hours
- Hemodynamic instability requiring use of pressors or >2 bolus
- Culture positive sepsis
- Clinical concern for meningitis or encephalopathy
- Sedation medication or other conditions/medications affecting CNS function
- Clinically obtained total bilirubin more than 15 on day of EEG
- Scalp injury preventing placement of EEG leads
- Point-of-care testing (POCT) glucose <45 at time of EEG
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