Diabetes in PregnancyNCT02968628
Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)
An observational study of Diabetes in Pregnancy and Diabetes, Gestational, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 120 hoursHealthy volunteers can take part
- Conditions the study is for
- Diabetes in Pregnancy, Diabetes, Gestational, Infant, Newborn, Diseases
- What is being tested?
- Video Electroencephalogram (EEG), Point-of Care Blood Sugar Testing and Medical Record Data Extraction
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 1 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 120 hours
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- >/= 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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.
Read more
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
- Being tested
- Video Electroencephalogram (EEG), Point-of Care Blood Sugar Testing, Medical Record Data Extraction, Maternal Questionnaire
- Medical subject headings
- Diabetes, Gestational, Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Point-of Care Blood Sugar TestingOther
One-time heel-stick point-of-care blood sugar testing at time of EEG.
Medical Record Data ExtractionOther
Medical record data extraction from both maternal obstetric and neonatal medical record for variables known to impact EEG and neurodevelopmental outcomes.
Maternal QuestionnaireOther
One-time maternal questionnaire related to smoking practices, ETOH consumption, level of education, and body mass index.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Video Electroencephalogram (EEG); Other: Point-of Care Blood Sugar Testing; Other: Medical Record Data Extraction; Other: Maternal Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Interburst Interval on cEEG
Measured: Single EEG between 24 hours of life and 5 days of life
Lower Margin Amplitude on aEEG
Measured: Single EEG between 24 hours of life and 5 days of life
Secondary outcomes (2)
Number of Delta Brushes on cEEG
Measured: Single EEG between 24 hours of life and 5 days of life
Bandwidth on aEEG
Measured: Single EEG between 24 hours of life and 5 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes in PregnancyStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura M Price, MD, Principal investigator, University of RochesterRonnie Guillet, MD, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968628
- Sponsor's protocol ID
- RSRB00061973
- Status last verified
- Feb 2020
- First submitted
- 26 Aug 2016
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)
- ClinicalTrials.gov ID
- NCT02968628
- Acronym / sponsor ID
- RSRB00061973
- Conditions
- Diabetes in Pregnancy, Diabetes, Gestational, Infant, Newborn, Diseases, Perinatal Disorders of Growth and Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases: Infants of Diabetic Mothers | – | Other: Video Electroencephalogram (EEG), Other: Point-of Care Blood Sugar Testing, Other: Medical Record Data Extraction, Other: Maternal QuestionnaireCases: 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 | – | Other: Video Electroencephalogram (EEG), Other: Point-of Care Blood Sugar Testing, Other: Medical Record Data Extraction, Other: Maternal QuestionnaireControls: 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 |
Who may qualify
- Ages
- 24 to 120 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- >/= 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Cases: Infants of Diabetic Mothers, Controls |
| Point-of Care Blood Sugar TestingOne-time heel-stick point-of-care blood sugar testing at time of EEG. | Other | Cases: Infants of Diabetic Mothers, Controls |
| Medical Record Data ExtractionMedical record data extraction from both maternal obstetric and neonatal medical record for variables known to impact EEG and neurodevelopmental outcomes. | Other | Cases: Infants of Diabetic Mothers, Controls |
| Maternal QuestionnaireOne-time maternal questionnaire related to smoking practices, ETOH consumption, level of education, and body mass index. | Other | Cases: Infants of Diabetic Mothers, Controls |
Primary outcome
Maximum Interburst Interval on cEEG
Time frame: Single EEG between 24 hours of life and 5 days of life
Lower Margin Amplitude on aEEG
Time frame: Single EEG between 24 hours of life and 5 days of life
2 secondary outcomes
Number of Delta Brushes on cEEG
Time frame: Single EEG between 24 hours of life and 5 days of life
Bandwidth on aEEG
Time frame: Single EEG between 24 hours of life and 5 days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetes in Pregnancy
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura M Price, MD principal investigator
University of Rochester
Ronnie Guillet, MD, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes in Pregnancy and Diabetes, Gestational, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Interburst Interval on cEEG (time frame: Single EEG between 24 hours of life and 5 days of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.