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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 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 74 participants.

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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.

Interventions

  • DRUG Caffeine citrate

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2008-11
Est. Completion 2015-12
Phase Phase 4

What the Registry Record Tells You About NCT00809055

The ClinicalTrials.gov registry entry for NCT00809055 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Caffeine citrate is the first listed.

NCT00809055 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.