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NCT00957840 · ClinicalTrials.gov registry record · NA
Intraventricular Hemorrhage and Post Hemorrhagic Ventricular Dilation: Natural Course, Treatment, and Outcome
A NA study, sponsored by University of Utah.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT00957840 is a NA study that has completed, run by University of Utah. The registered enrollment target is 63 participants.
The verdict
NCT00957840, a NA study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study Summary
Intraventricular hemorrhage and its resultant post-hemorrhagic hydrocephalus are significant risk factors for the development of neurodevelopmental delays in preterm infants. The purpose of this study is to determine 1) the incidence of progressive post-hemorrhagic ventricular dilatation (PHVD) in infants with severe intraventricular hemorrhage (IVH), 2) the effect of ventricular dilatation on brain status (cerebral oxygenation, electrical activity, and biomarkers of cerebral damage and repair), and 3) if using ventricular measurements, derived from cranial ultrasound to guide removal of cerebral-spinal fluid through an Omaya reservoir, will help resolve ventricular dilatation and decrease the need for ventriculo-peritoneal (VP) shunt insertion. The hypothesis of this research project is that, by using ventricular measurements to guide the frequency of CSF removal, the rate of VP shunt insertion will be decreased in preterm infants with severe IVH and PHVD. The investigators further hypothesize that cerebral injury, as measured by cerebrospinal fluid (CSF) concentration of biomarkers of neuronal and glial damage and inflammation, will decrease over time with resolution of PHVD.
Interventions
- PROCEDURE NIRS, aEEG, and CSF concentration of biomarkers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2009-07 |
| Est. Completion | 2015-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00957840
The ClinicalTrials.gov registry entry for NCT00957840 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NIRS, aEEG, and CSF concentration of biomarkers is the first listed.
NCT00957840 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00957840 about?
NCT00957840 is a clinical study titled "Intraventricular Hemorrhage and Post Hemorrhagic Ventricular Dilation: Natural Course, Treatment, and Outcome". Intraventricular hemorrhage and its resultant post-hemorrhagic hydrocephalus are significant risk factors for the development of neurodevelopmental delays in preterm infants. The purpose of this study is to determine 1) the incidence of progressive post-hemorrhagic ventricular dilatation (PHVD) in i...
What is the current status of trial NCT00957840?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2009-07. Estimated completion is 2015-04.
What interventions are being tested in trial NCT00957840?
The interventions under investigation include: NIRS, aEEG, and CSF concentration of biomarkers (PROCEDURE).
Who is sponsoring clinical trial NCT00957840?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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