STeroids to REduce Systemic Inflammation After Infant Heart Surgery
Public ClinicalTrials.gov record NCT03229538. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD), safety and efficacy of methylprednisolone in infants undergoing heart surgery with cardiopulmonary bypass. This is a prospective, double blind, multi-center, placebo-controlled safety and efficacy study. Blood samples will be collected from a subset of enrolled study participants to evaluate multiple dose methylprednisolone PK/PD. Participants will be randomized in a 1:1 fashion to intravenous methylprednisolone versus placebo. Study drug/placebo will be administered 8 to 12 hours before the anticipated start time of surgery and in the operating room at the time of initiation of cardiopulmonary bypass. Patients will be followed for primary and secondary outcomes for the duration of their hospitalization. Serious study drug-related adverse events will be collected for 7 days after the last dose of study drug.
Study identification
- NCT ID
- NCT03229538
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,263 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- Up to 12 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 18, 2017 (Actual)
- Primary completion
- Mar 31, 2022 (Actual)
- Completion
- Mar 31, 2022 (Actual)
- Last update posted
- Jan 5, 2026
2017 – 2022
United States locations
- U.S. sites
- 23
- U.S. states
- 17
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| University of Colorado, Denver | Aurora | Colorado | 80045 | — |
| University of Florida Health - Shands Hospital | Gainesville | Florida | 32608 | — |
| Ann & Robert Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611-2605 | — |
| Advocate Children's Hospital | Oak Lawn | Illinois | 60453 | — |
| Johns Hopkins University | Baltimore | Maryland | 21205 | — |
| Children's Hospital and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | — |
| Children's Hospital and Medical Center | Omaha | Nebraska | 68114 | — |
| Morgan Stanley Children's Hospital of New York Presbyterian | New York | New York | 10032-3702 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390-9020 | — |
| Baylor College of Medicine, Texas Children's Hospital | Houston | Texas | 77030 | — |
| Utah/Primary Children's Medical Center | Salt Lake City | Utah | 84113 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03229538, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 5, 2026 · Synced Nov 1, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03229538 live on ClinicalTrials.gov.