Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03229538 · ClinicalTrials.gov registry record · Phase 3
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
A Phase 3 study of Inflammatory Response and Congenital Heart Disease in Children, sponsored by Kevin Hill.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,263
- Enrollment target
- 20
- Study locations
NCT03229538: Completed Phase 3 study of Inflammatory Response and Congenital Heart Disease in Children, sponsored by Kevin Hill.
NCT03229538 is a Phase 3 study of Inflammatory Response and Congenital Heart Disease in Children that has completed, run by Kevin Hill. The registered enrollment target is 1,263 participants, above the 99-participant average among 16 other Inflammatory Response trials with a reported enrollment target (1176% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03229538, a Phase 3 study of Inflammatory Response and Congenital Heart Disease in Children, has completed, sponsored by Kevin Hill.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,263 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
A composite mortality, major morbidity and length of stay global rank endpoint with endpoints ranked according to severity. For this endpoint, each randomized patient will be assigned a rank based upon their most-severe outcome. Rank of 91 = Post-operative length of stay \> 90 days, 92 = Post-op cardiac arrest, multi-system organ failure, renal failure with temporary dialysis, or prolonged ventilator support, 93 = Reoperation for bleeding, unplanned delayed sternal closure, or post-op unplanned
Conditions Studied
Interventions
- DRUG Methylprednisolone
- DRUG Isotonic saline
Study Locations (20)
Ohio
- Children's Hospital Medical Center - Cincinnati
- Cleveland Clinic - Cleveland
- Nationwide Children's Hospital - Columbus
Illinois
- Ann & Robert Lurie Children's Hospital of Chicago - Chicago
- Advocate Children's Hospital - Oak Lawn
Missouri
- Children's Mercy Hospital - Kansas City
- St. Louis Children's Hospital - St Louis
New York
- Morgan Stanley Children's Hospital of New York Presbyterian - New York
- University of Rochester Medical Center - Rochester
California
- Children's Hospital of Los Angeles - Los Angeles
Colorado
- University of Colorado, Denver - Aurora
Florida
- University of Florida Health - Shands Hospital - Gainesville
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,263 participants |
| Start Date | 2017-10-18 |
| Est. Completion | 2022-03-31 |
| Phase | Phase 3 |
What the finished NCT03229538 record still lists
NCT03229538 is an interventional study that assigns participants to a tested intervention. Its 1,263 participants enrollment target places it among the larger protocols in the corpus, above the 99-participant average among 16 other Inflammatory Response trials with a reported enrollment target (1176% higher).
The record links to 2 conditions, with Inflammatory Response appearing as the primary indexed condition, and to 2 interventions - of which Methylprednisolone is the first listed.
NCT03229538 names 20 study sites across 15 states, led by Ohio, Illinois, Missouri.
Frequently Asked Questions
What is clinical trial NCT03229538 about?
NCT03229538 is a clinical study titled "STeroids to REduce Systemic Inflammation After Infant Heart Surgery". 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 sa...
What is the current status of trial NCT03229538?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,263 participants. The study started on 2017-10-18. Estimated completion is 2022-03-31.
What conditions does trial NCT03229538 study?
This clinical trial studies the following conditions: Inflammatory Response, Congenital Heart Disease in Children.
What interventions are being tested in trial NCT03229538?
The interventions under investigation include: Methylprednisolone (DRUG), Isotonic saline (DRUG).
Who is sponsoring clinical trial NCT03229538?
This trial is sponsored by Kevin Hill, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03229538 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Inflammatory Response
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03229538's enrollment target sits among peer trials
1,263 1st of 16 higher than 16 of 16 other Inflammatory Response trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammatory Response 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
-
Menthol, Inflammation, and Nicotine Transition Study
RECRUITING · NA
-
Examining the Role of Female Endogenous Sex Hormones in Eccentric Exercise
RECRUITING · NA
-
Association Between Body Composition and Pain in Spinal Cord Injury
RECRUITING · NA
-
Social Experiences and Demographic Factors in the Regulation of Immune Cells
RECRUITING · NA
-
Daoist Zhanzhuang and Human Flourishing
RECRUITING · NA
-
Investigating Age-dependent Effects of Egg Intake on HDL and Immune Profiles
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06119581 · 1,264 participants · Phase 3
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
- NCT06712316 · 1,260 participants · Phase 2
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
- NCT06812273 · 1,260 participants · NA
Mediators and Moderators of Auditory Training
- NCT06931340 · 1,260 participants · Phase 3
Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI