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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 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.

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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.

Conditions Studied

Inflammatory Response Congenital Heart Disease in Children

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

FieldValue
Enrollment Target 1,263 participants
Start Date 2017-10-18
Est. Completion 2022-03-31
Phase Phase 3

Sponsor

Kevin Hill

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03229538

The ClinicalTrials.gov registry entry for NCT03229538 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,263 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 99-participant average among 16 other Inflammatory Response trials with a reported enrollment target (1176% higher). The listed sponsor is Kevin Hill, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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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.