Trial of Steroids in Pediatric Acute Lung Injury/ARDS (SPALIT)
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|ClinicalTrials.gov Identifier: NCT01274260|
Recruitment Status : Unknown
Verified May 2014 by University of Tennessee.
Recruitment status was: Active, not recruiting
First Posted : January 11, 2011
Last Update Posted : May 28, 2014
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome (ARDS) Acute Lung Injury (ALI)||Drug: methylprednisolone Drug: Normal Saline (0.9%)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||December 2014|
Active Comparator: Experimental Group
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.
Subjects in this 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.
Placebo Comparator: Placebo Group
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.
Drug: Normal Saline (0.9%)
The placebo will be 0.9% (normal) saline and the active medication will be diluted in 0.9% (normal) saline.
- Duration of mechanical ventilation [ Time Frame: 0-28 days ]Number of hours required for positive pressure ventilation after the start of study drug
- Improvement in oxygenation [ Time Frame: 0-28 days ]Differences in the PaO2/FiO2 ratios between the two randomized groups
- Incidence of nosocomial infections [ Time Frame: 0-35 days ]Infection surveillance will be in the form of tracheal aspirate for gram stain and culture done prior to study entry and then every 3-5 days. If a subject spikes a fever during the study drug infusion, they will have blood, urine and tracheal aspirate cultures done along with CBC and CRP. Number of nosocomial infections documented via surveillance cultures will be compared between groups.
- Incidence of hyperglycemia [ Time Frame: 0-28 days ]Number of times that the subject has a Blood Glucose >180 mg/dL (10 mmol/L) will be compared between the randomized groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274260
|United States, Tennessee|
|Le Bonheur Children's Hospital|
|Memphis, Tennessee, United States, 38103|