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

Completed

• Conditions: Perinatal Disorders of Growth and Development; Diabetes, Gestational; Diabetes in Pregnancy; Infant, Newborn, Diseases
• Interventions: Other: Video Electroencephalogram (EEG); Other: Point-of Care Blood Sugar Testing; Other: Medical Record Data Extraction; Other: Maternal Questionnaire

• Registration Number: NCT02968628
• Lead Sponsor: University of Rochester

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. .

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-26
• Study Start: 2016-09-01
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases: Infants of Diabetic Mothers	Point-of Care Blood Sugar Testing	Cases: Neonates born at or over 35 weeks gestation whose mother's were recommended to receive medication for diabetes during pregnancy. This includes pre-gestational and gestational diabetics. Interventions: 1. Video Electroencephalogram (EEG) 2. Point-of Care Blood Sugar Testing 3. Medical Record Data Extraction 4. Maternal Questionnaire
Cases: Infants of Diabetic Mothers	Maternal Questionnaire	Cases: Neonates born at or over 35 weeks gestation whose mother's were recommended to receive medication for diabetes during pregnancy. This includes pre-gestational and gestational diabetics. Interventions: 1. Video Electroencephalogram (EEG) 2. Point-of Care Blood Sugar Testing 3. Medical Record Data Extraction 4. Maternal Questionnaire
Cases: Infants of Diabetic Mothers	Video Electroencephalogram (EEG)	Cases: Neonates born at or over 35 weeks gestation whose mother's were recommended to receive medication for diabetes during pregnancy. This includes pre-gestational and gestational diabetics. Interventions: 1. Video Electroencephalogram (EEG) 2. Point-of Care Blood Sugar Testing 3. Medical Record Data Extraction 4. Maternal Questionnaire
Cases: Infants of Diabetic Mothers	Medical Record Data Extraction	Cases: Neonates born at or over 35 weeks gestation whose mother's were recommended to receive medication for diabetes during pregnancy. This includes pre-gestational and gestational diabetics. Interventions: 1. Video Electroencephalogram (EEG) 2. Point-of Care Blood Sugar Testing 3. Medical Record Data Extraction 4. Maternal Questionnaire
Controls	Video Electroencephalogram (EEG)	Controls: Neonates born at or over 35 weeks gestation whose mother's had normal glycemic control testing during pregnancy. Interventions: 1. Video Electroencephalogram (EEG) 2. Point-of Care Blood Sugar Testing 3. Medical Record Data Extraction 4. Maternal Questionnaire
Controls	Point-of Care Blood Sugar Testing	Controls: Neonates born at or over 35 weeks gestation whose mother's had normal glycemic control testing during pregnancy. Interventions: 1. Video Electroencephalogram (EEG) 2. Point-of Care Blood Sugar Testing 3. Medical Record Data Extraction 4. Maternal Questionnaire
Controls	Medical Record Data Extraction	Controls: Neonates born at or over 35 weeks gestation whose mother's had normal glycemic control testing during pregnancy. Interventions: 1. Video Electroencephalogram (EEG) 2. Point-of Care Blood Sugar Testing 3. Medical Record Data Extraction 4. Maternal Questionnaire
Controls	Maternal Questionnaire	Controls: Neonates born at or over 35 weeks gestation whose mother's had normal glycemic control testing during pregnancy. Interventions: 1. Video Electroencephalogram (EEG) 2. Point-of Care Blood Sugar Testing 3. Medical Record Data Extraction 4. Maternal Questionnaire

Primary Outcome Measures

Name	Time	Method
Lower Margin Amplitude on aEEG	Single EEG between 24 hours of life and 5 days of life
Maximum Interburst Interval on cEEG	Single EEG between 24 hours of life and 5 days of life

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States