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NCT00665769 · ClinicalTrials.gov registry record · NA
Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage
A NA study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 103
- Enrollment target
NCT00665769 is a NA study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 103 participants.
The verdict
NCT00665769, a NA study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 103 participants
- Enrollment target
Study Summary
Annually, almost 5,000 extremely low birth weight (9 ounces to about 2 lbs) infants born in the US survive with severe bleeding in the brain (intraventricular hemorrhage); this devastating complication of prematurity is associated with many problems, including mental retardation, cerebral palsy, and learning disabilities, that result in profound individual and familial consequences. In addition, lifetime care costs for these severely affected infants born in a single year exceed $3 billion. The huge individual and societal costs underscore the need for developing care strategies that may limit severe bleeding in the brain of these tiny infants. The overall goal of our research is to evaluate disturbances of brain blood flow in these tiny infants in order to predict which of them are at highest risk and to develop better intensive care techniques that will limit severe brain injury. 1. Since most of these infants require ventilators (respirators) to survive, we will investigate how 2 different methods of ventilation affect brain injury. We believe that a new method of ventilation, allowing normal carbon dioxide levels, will normalize brain blood flow and lead to less bleeding in the brain. 2. We will also examine how treatment for low blood pressure in these infants may be associated with brain injury. We believe that most very premature infants with low blood pressure actually do worse if they are treated. We think that by allowing the infants to normalize blood pressure on their own will allow them to stabilize blood flow to the brain leading to less intraventricular hemorrhage. 3. In 10 premature infants with severe brain bleeding, we have developed a simple technique to identify intraventricular hemorrhage before it happens. Apparently, the heart rate of infants who eventually develop severe intraventricular hemorrhage is less variable than infants who do not develop this. We plan to test this method in a large group of infants, to be able to predict which infan
Interventions
- OTHER Hypercapnia
- OTHER Normocapnia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2008-06 |
| Est. Completion | 2015-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00665769
The ClinicalTrials.gov registry entry for NCT00665769 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hypercapnia is the first listed.
NCT00665769 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00665769 about?
NCT00665769 is a clinical study titled "Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage". Annually, almost 5,000 extremely low birth weight (9 ounces to about 2 lbs) infants born in the US survive with severe bleeding in the brain (intraventricular hemorrhage); this devastating complication of prematurity is associated with many problems, including mental retardation, cerebral palsy, and...
What is the current status of trial NCT00665769?
This trial is currently terminated. It is a NA study. The enrollment target is 103 participants. The study started on 2008-06. Estimated completion is 2015-11.
What interventions are being tested in trial NCT00665769?
The interventions under investigation include: Hypercapnia (OTHER), Normocapnia (OTHER).
Who is sponsoring clinical trial NCT00665769?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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