Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01579513 · ClinicalTrials.gov registry record · NA
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
A NA study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 190
- Enrollment target
NCT01579513 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 190 participants.
The verdict
NCT01579513, a NA study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 190 participants
- Enrollment target
Study Summary
Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent inflammatory response secondary to the body's recognition of the abnormal environment of the heart-lung machine. This inflammatory response may lead to poor heart, lung and kidney function after the heart surgery. This is turn can lead to longer times on the ventilator (breathing machine), the need for higher doses of heart medications, a longer stay in the intensive care unit and even death. This is particularly true in infants less than one month of age due to their size and the immaturity of their organs. The appreciation of the post-cardiopulmonary bypass inflammatory response has resulted in a number of interventions directed at its reduction. No therapy has been recognized as the standard of care; however steroid therapy has been applied most often despite unclear evidence of a benefit. This study aims to determine if steroids improve the outcomes of babies undergoing heart surgery.
Interventions
- DRUG Placebo
- DRUG Methylprednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2012-06 |
| Est. Completion | 2018-12-19 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01579513
The ClinicalTrials.gov registry entry for NCT01579513 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01579513 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01579513 about?
NCT01579513 is a clinical study titled "Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass". Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent inflammatory response secondary to the body's recognition of the abnormal environment of the heart-lung machine. This inflammatory...
What is the current status of trial NCT01579513?
This trial is currently completed. It is a NA study. The enrollment target is 190 participants. The study started on 2012-06. Estimated completion is 2018-12-19.
What interventions are being tested in trial NCT01579513?
The interventions under investigation include: Placebo (DRUG), Methylprednisolone (DRUG).
Who is sponsoring clinical trial NCT01579513?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.