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Sponsor study identifier
observational
39
1 country
1
Study Start
September 1, 2016
Actual (reported)Primary Completion
October 1, 2018
Actual (reported)Study Completion
October 1, 2018
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 26, 2016
Actual (reported)September 1, 2016
Actual (reported)November 18, 2016
Actual (reported)October 1, 2018
Actual (reported)October 1, 2018
Actual (reported)Maximum Interburst Interval on cEEG
Single EEG between 24 hours of life and 5 days of life
Lower Margin Amplitude on aEEG
Single EEG between 24 hours of life and 5 days of life
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
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: 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
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.
One-time heel-stick point-of-care blood sugar testing at time of EEG.
The study population will be a convenience sample, comprised of singleton neonates born at or after 35 weeks post-menstrual age at the University of Rochester Medical Center (URMC). Cases will be infants of mothers with either a diagnoses of pre-gestational diabetes or gestational diabetes whose provider recommends treatment with insulin or oral glycemic agents. Controls will be neonates whose mothers had normal glucose testing during gestation and pre-pregnancy BMI of \<30. All subjects will be otherwise healthy, as defined by the exclusion criteria. There is no intended racial, ethnic or gender distribution of these neonates.
University of Rochester Medical Center
Rochester, New York, 14642, United States
Laura M Price, MD
University of Rochester
Ronnie Guillet, MD, PhD
University of Rochester
39 participants (actual enrollment reported by the registry).
First Submitted
August 26, 2016
First Posted
November 18, 2016
Study Start
September 1, 2016
Actual (reported)Medical record data extraction from both maternal obstetric and neonatal medical record for variables known to impact EEG and neurodevelopmental outcomes.
One-time maternal questionnaire related to smoking practices, ETOH consumption, level of education, and body mass index.
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Primary Completion
October 1, 2018
Actual (reported)Study Completion
October 1, 2018
Actual (reported)Last Updated
February 17, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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