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

NCT02968628 | Completed

• 1 other identifier: RSRB00061973
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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. .

Conditions

Diabetes in Pregnancy; Diabetes, Gestational; Infant, Newborn, Diseases; Perinatal Disorders of Growth and Development

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• 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 Arms (2)

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); Other: Point-of Care Blood Sugar Testing; Other: Medical Record Data Extraction; Other: Maternal Questionnaire

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); Other: Point-of Care Blood Sugar Testing; Other: Medical Record Data Extraction; Other: Maternal Questionnaire

Interventions

Video Electroencephalogram (EEG) OTHER

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.

Cases: Infants of Diabetic Mothers; Controls

Point-of Care Blood Sugar Testing OTHER

One-time heel-stick point-of-care blood sugar testing at time of EEG.

Cases: Infants of Diabetic Mothers; Controls

Medical Record Data Extraction OTHER

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

Cases: Infants of Diabetic Mothers; Controls

Maternal Questionnaire OTHER

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

Cases: Infants of Diabetic Mothers; Controls

Eligibility Criteria

• Age: 24 Hours - 120 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• \>/= 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Laura M Price, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Ronnie Guillet, MD, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: November 18, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)