Trial of Steroids in Pediatric Acute Lung Injury/ARDS
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 5/5/2014 |
| Start Date: | October 2010 |
| End Date: | December 2012 |
| Contact: | Bonny Bardhan, M.D. |
| Email: | bonnybardhan@msn.com |
| Phone: | (734) 731-4486 |
Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial
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.
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.
Inclusion Criteria:
1. Between 1 month and 18 years of age; AND
2. Admitted to the PICU with a diagnosis of ALI or ARDS, as defined by:
1. acute onset of the disease,
2. PaO2/FiO2 ratio <300,
3. evidence of bilateral infiltrates on chest radiography, and
4. no evidence of cardiac dysfunction; AND
3. Intubated and mechanically ventilated.
Exclusion Criteria:
1. Underlying disease requiring steroids >0.5mg/kg/day of methylprednisolone (eg.
Asthma)
2. HIV positive, or have any other congenital or acquired immunodeficiency;
3. Terminally ill patients or patients on hospice care or if there is a lack of
commitment to aggressive intensive care
4. Cytotoxic therapy within the past 3 weeks
5. Major gastrointestinal bleeding within last 1 month
6. Extensive burns (>20% total body surface area of full- or partial-thickness burns)
7. Known or suspected adrenal insufficiency
8. Vasculitis or diffuse alveolar hemorrhage
9. Bone marrow or lung transplant
10. Disseminated fungal infections
11. Severe chronic liver disease
12. Other conditions with estimated 6-month mortality of 50% or higher
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