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NCT02968628 · ClinicalTrials.gov registry record
Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)
A clinical trial of Infant, Newborn, Diseases and Diabetes, Gestational, sponsored by University of Rochester.
- Completed
- Registry status
- 39
- Enrollment target
- 1
- Study location
NCT02968628: Completed study of Infant, Newborn, Diseases and Diabetes, Gestational, sponsored by University of Rochester.
NCT02968628 is a study of Infant, Newborn, Diseases and Diabetes, Gestational that has completed, run by University of Rochester. The registered enrollment target is 39 participants, below the 758-participant average among 8 other Infant, Newborn, Diseases trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02968628, a study of Infant, Newborn, Diseases and Diabetes, Gestational, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- 39 participants
- Enrollment target
- 1
- Study location
Study 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 orde
Conditions Studied
Interventions
- OTHER Video Electroencephalogram (EEG)
- OTHER Point-of Care Blood Sugar Testing
- OTHER Medical Record Data Extraction
- OTHER Maternal Questionnaire
Study Locations (1)
New York
- University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2016-09-01 |
| Est. Completion | 2018-10-01 |
What the finished NCT02968628 record still lists
NCT02968628 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 758-participant average among 8 other Infant, Newborn, Diseases trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Infant, Newborn, Diseases appearing as the primary indexed condition, and to 4 interventions - of which Video Electroencephalogram (EEG) is the first listed.
NCT02968628 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02968628 about?
NCT02968628 is a clinical study titled "Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)". 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, h...
What is the current status of trial NCT02968628?
This trial is currently completed. The enrollment target is 39 participants. The study started on 2016-09-01. Estimated completion is 2018-10-01.
What conditions does trial NCT02968628 study?
This clinical trial studies the following conditions: Infant, Newborn, Diseases, Diabetes, Gestational, Diabetes in Pregnancy, Perinatal Disorders of Growth and Development.
What interventions are being tested in trial NCT02968628?
The interventions under investigation include: Video Electroencephalogram (EEG) (OTHER), Point-of Care Blood Sugar Testing (OTHER), Medical Record Data Extraction (OTHER), Maternal Questionnaire (OTHER).
Who is sponsoring clinical trial NCT02968628?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02968628 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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