CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 77 enrolled
Drug / intervention
methylprednisolone (IVMP) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00934843
NCT00934843N/ACompleted
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Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Medical University of South Carolina·interventional·Posted Jul 8, 2009·Updated Dec 9, 2011

In Brief

A clinical study evaluating methylprednisolone (IVMP) and methylprednisolone (two doses IVMP) for Congenital Heart Disease and Disorder of Fetus or Newborn. Completed, enrolled 77 participants across 1 site.

Detailed Summary

Randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Disease, Disorder of Fetus or Newborn
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 8, 2009
Enrollment StartMar 1, 2007
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.0 years ago

Interventions

methylprednisolone (IVMP)drug

Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB)machine in the first month of life that receive ONE doses intravenous methylprednisolone (IVMP) prior to heart surgery.Compare the effects and preoperative and intraoperative IVMP (2 dose steroid)to intraoperative IVMP alone (single dose steroid) on the inflammatory response to CPB cardiopulmonary bypass.

methylprednisolone (two doses IVMP)drug

Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB)machine in the first month of life that receive TWO doses intravenous methylprednisolone (IVMP) prior to heart surgery.Compare the effects and preoperative and intraoperative IVMP to intraoperative IVMP alone on the inflammatory response to CPB cardiopulmonary bypass. The hypothesis is that neonates treated with preoperative IVMP as well as the standard intraoperative IVMP will have decreased production of pro-inflammatory cytokines.