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

May 23, 2014 updated by: University of Tennessee

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Le Bonheur Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: methylprednisolone
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of mechanical ventilation
Time Frame: 0-28 days
Number of hours required for positive pressure ventilation after the start of study drug
0-28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in oxygenation
Time Frame: 0-28 days
Differences in the PaO2/FiO2 ratios between the two randomized groups
0-28 days
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.
0-35 days
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
0-28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

January 9, 2011

First Submitted That Met QC Criteria

January 10, 2011

First Posted (Estimate)

January 11, 2011

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 23, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Steroids in Pediatic ALI/ARDS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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