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临床试验/NCT02968628
NCT02968628已完成不适用

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

University of Rochester1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
Maximum Interburst Interval on cEEG

研究概览

简要总结

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. .

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
24 Hours 至 120 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • >/= 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

排除标准

  • 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

结局指标

主要结局

Maximum Interburst Interval on cEEG

时间窗: Single EEG between 24 hours of life and 5 days of life

Lower Margin Amplitude on aEEG

时间窗: Single EEG between 24 hours of life and 5 days of life

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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