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

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ClinicalTrials.gov Identifier: NCT02968628
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Laura Price, 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. .


Condition or disease Intervention/treatment
Diabetes in Pregnancy Diabetes, Gestational Infant, Newborn, Diseases Perinatal Disorders of Growth and Development Other: Video Electroencephalogram (EEG) Other: Point-of Care Blood Sugar Testing Other: Medical Record Data Extraction Other: Maternal Questionnaire

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)
Study Start Date : September 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases: Infants of Diabetic Mothers

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
Other: Video 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.

Other: Point-of Care Blood Sugar Testing
One-time heel-stick point-of-care blood sugar testing at time of EEG.

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

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

Controls

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
Other: Video 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.

Other: Point-of Care Blood Sugar Testing
One-time heel-stick point-of-care blood sugar testing at time of EEG.

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

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




Primary Outcome Measures :
  1. Maximum Interburst Interval on cEEG [ Time Frame: Single EEG between 24 hours of life and 5 days of life ]
  2. Lower Margin Amplitude on aEEG [ Time Frame: Single EEG between 24 hours of life and 5 days of life ]

Secondary Outcome Measures :
  1. Number of Delta Brushes on cEEG [ Time Frame: Single EEG between 24 hours of life and 5 days of life ]
  2. Bandwidth on aEEG [ Time Frame: Single EEG between 24 hours of life and 5 days of life ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968628


Contacts
Contact: Laura M Price, MD 585-275-1847 laura_price@urmc.rochester.edu
Contact: Ronnie Guillet, MD, PhD 585-275-2972 ronnie_guillet@urmc.rochester.edu

Locations
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Laura Price         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Laura M Price, MD University of Rochester
Principal Investigator: Ronnie Guillet, MD, PhD University of Rochester

Responsible Party: Laura Price, Fellow Perinatal-Neonatal Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT02968628     History of Changes
Other Study ID Numbers: RSRB00061973
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Infant, Newborn, Diseases
Diabetes, Gestational
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications