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Corticosteroid

Experimental Group for Acute Respiratory Distress Syndrome (SPALIT Trial)

Phase 2
Waitlist Available
Research Sponsored by University of Tennessee
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-35 days
Awards & highlights

SPALIT Trial Summary

Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are devastating disorders associated with lung inflammation, low oxygen levels and respiratory failure in children. Prevalence of ALI ranges from 2.2 to 12 per 100,000 children per year. Using these estimates, up to 9,000 children each year will develop ALI/ARDS, which may cause upto 2,000 deaths per year. Currently, there are no specific therapies directed against ARDS/ALI in children. In adult patients, use of steroids early in the course of ARDS appears promising. There are no published clinical trials examining the use of steroids for the treatment of ALI/ARDS in children. Hypothesis: Subjects with ALI/ARDS receiving steroids early in the course of disease (within 72 hours) and longer than 7 days will have improved clinical outcomes as compared to placebo control group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly increased PaO2/FiO2 ratios.

Eligible Conditions
  • Acute Respiratory Distress Syndrome
  • Acute Lung Injury

SPALIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-35 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-35 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of mechanical ventilation
Secondary outcome measures
Improvement in oxygenation
Incidence of hyperglycemia
Incidence of nosocomial infections

SPALIT Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Experimental GroupActive Control1 Intervention
Intervention: Subjects in this study group will receive a loading dose of methylprednisolone 2mg/kg followed by 1mg/kg/day of methylprednisolone infusion from day 1 to day 7; 0.5mg/kg/d from days 8 to 10, 0.25mg/kg/d on days 11 and 12, 0.125mg/kg/d on days 13 and 14. The study drug infusion will be discontinued after 14 days.
Group II: Placebo GroupPlacebo Group1 Intervention
Intervention: The placebo will be 0.9% (normal) saline and the active medication will be diluted in 0.9% (normal) saline. The placebo group with receive the masked study drug in infusion rates that mimic the infusions received by the experimental group.

Find a Location

Who is running the clinical trial?

University of TennesseeLead Sponsor
191 Previous Clinical Trials
143,954 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Frontiers in PediatricsJournal
Plasma Biomarker Analysis in Pediatric ARDS: Generating Future Framework from a Pilot Randomized Control Trial of Methylprednisolone: A Framework for Identifying Plasma Biomarkers Related to Clinical Outcomes in Pediatric ARDS
Kimura, Dai, Jordy Saravia, Cynthia R. Rovnaghi, Gianfranco Umberto Meduri, Andreas Schwingshackl, Stephania A. Cormier, and Kanwaljeet J. Anand. 2016. “Plasma Biomarker Analysis in Pediatric ARDS: Generating Future Framework from a Pilot Randomized Control Trial of Methylprednisolone: A Framework for Identifying Plasma Biomarkers Related to Clinical Outcomes in Pediatric ARDS”. Frontiers in Pediatrics. Frontiers Media SA. doi:10.3389/fped.2016.00031.
clinicaltrials.govStudy
Trial of Steroids in Pediatric Acute Lung Injury/ARDS
2010. "Trial of Steroids in Pediatric Acute Lung Injury/ARDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01274260.
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~7 spots leftby May 2025
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