Trial of Steroids in Pediatric Acute Lung Injury/ARDS (SPALIT)
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.
Acute Respiratory Distress Syndrome (ARDS)
Acute Lung Injury (ALI)
Drug: Normal Saline (0.9%)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial|
- Duration of mechanical ventilation [ Time Frame: 0-28 days ] [ Designated as safety issue: No ]Number of hours required for positive pressure ventilation after the start of study drug
- Improvement in oxygenation [ Time Frame: 0-28 days ] [ Designated as safety issue: No ]Differences in the PaO2/FiO2 ratios between the two randomized groups
- Incidence of nosocomial infections [ Time Frame: 0-35 days ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Number of times that the subject has a Blood Glucose >180 mg/dL (10 mmol/L) will be compared between the randomized groups
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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.
|Contact: Bonny Bardhan, M.D.||(734) email@example.com|
|Contact: Kanwaljeet S. Anand, MBBS, D.Phil.||firstname.lastname@example.org|
|United States, Tennessee|
|Le Bonheur Children's Hospital||Recruiting|
|Memphis, Tennessee, United States, 38103|
|Contact: Bonny Bardhan, M.D. (734) 731-4486 email@example.com|
|Contact: Kanwaljeet S. Anand, MBBS, D.Phil. 901-287-6303 firstname.lastname@example.org|
|Principal Investigator: Bonny Bardhan, M.D.|