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NCT00809055 · ClinicalTrials.gov registry record · Phase 4
MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine
A Phase 4 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 74
- Enrollment target
NCT00809055: Completed Phase 4 study, sponsored by Washington University School of Medicine.
NCT00809055 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 74 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00809055, a Phase 4 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 74 participants
- Enrollment target
Study Summary
Over the last 30 years the survival rates for babies born prematurely have improved greatly with research. As these babies grow up, we have found that many of the premature babies have learning and movement problems. The purpose of this research is to learn why premature infants are at risk for learning disabilities and movement problems later in childhood and whether this is changed by caffeine therapy. Caffeine is often used in premature babies to help them to breathe on their own. Nearly all babies born before 30 weeks gestation receive caffeine while they are in the neonatal intensive care unit (NICU). Scientists have shown that caffeine therapy given to premature babies reduces their disabilities. We will use brain monitoring, including electro-encephalogram (EEG) and magnetic resonance imaging (MRI) to understand how the brain of a premature baby develops and whether caffeine in high doses enhances protection of the developing brain. Just as we monitor the heart and lungs to improve our care of premature babies, we wish to monitor the brain so that we can understand how to improve our care for the brain.
Primary Outcome
Apparent diffusion coefficient is a measure of microstructural maturation obtained from brain MRI.
Interventions
- DRUG Caffeine citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2008-11 |
| Est. Completion | 2015-12 |
| Phase | Phase 4 |
What the finished NCT00809055 record still lists
NCT00809055 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Caffeine citrate is the first listed.
NCT00809055 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00809055 about?
NCT00809055 is a clinical study titled "MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine". Over the last 30 years the survival rates for babies born prematurely have improved greatly with research. As these babies grow up, we have found that many of the premature babies have learning and movement problems. The purpose of this research is to learn why premature infants are at risk for lear...
What is the current status of trial NCT00809055?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 74 participants. The study started on 2008-11. Estimated completion is 2015-12.
What interventions are being tested in trial NCT00809055?
The interventions under investigation include: Caffeine citrate (DRUG).
Who is sponsoring clinical trial NCT00809055?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00809055's enrollment target sits among peer trials
74 1027th of 2000 higher than 968 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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