Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02968628 : Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)
PhaseN/A
AgesMin: N/A Max: 120 Hours
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02968628      |      Link to official Clinicaltrials.gov listing
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