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

This study is currently recruiting participants.
Verified July 2011 by University of Tennessee
Sponsor:
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT01274260
First received: January 9, 2011
Last updated: July 11, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Distress Syndrome (ARDS)
Acute Lung Injury (ALI)
 Drug: methylprednisolone
Drug: Normal Saline (0.9%)
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274260

Contacts
Contact: Bonny Bardhan, M.D. (734) 731-4486 bonnybardhan@msn.com
Contact: Kanwaljeet S. Anand, MBBS, D.Phil. 901-287-6303 kanand@uthsc.edu

Locations
United States, Tennessee
Le Bonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38103
Contact: Bonny Bardhan, M.D.     (734) 731-4486     bonnybardhan@msn.com    
Contact: Kanwaljeet S. Anand, MBBS, D.Phil.     901-287-6303     kanand@uthsc.edu    
Principal Investigator: Bonny Bardhan, M.D.            
Sponsors and Collaborators
University of Tennessee
  More Information

No publications provided

Responsible Party: Kanwaljeet J. S. Anand, MBBS, D.Phil., THE UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER
ClinicalTrials.gov Identifier: NCT01274260     History of Changes
Other Study ID Numbers: Steroids in Pediatic ALI/ARDS
Study First Received: January 9, 2011
Last Updated: July 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
child
infant
lung injury
 inflammation
pneumonia
ventilator

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
 Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids

ClinicalTrials.gov processed this record on October 18, 2012