Trial of Steroids in Pediatric Acute Lung Injury/ARDS (SPALIT)

University of Tennessee

Status and phase: Unknown; Phase 2

Conditions: Acute Respiratory Distress Syndrome (ARDS); Acute Lung Injury (ALI)

Treatments: Drug: Normal Saline (0.9%); Drug: methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT01274260

Steroids in Pediatic ALI/ARDS

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Experimental Group

Active Comparator group

Description:

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.

Treatment:

Drug: methylprednisolone

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal Saline (0.9%)