NCT01274260

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

3.3 years

First QC Date

January 9, 2011

Last Update Submit

May 23, 2014

Conditions

Acute Respiratory Distress Syndrome (ARDS)Acute Lung Injury (ALI)

Keywords

childinfantlung injuryinflammationpneumoniaventilator

Outcome Measures

Primary Outcomes (1)

  • Duration of mechanical ventilation

    Number of hours required for positive pressure ventilation after the start of study drug

    0-28 days

Secondary Outcomes (3)

  • Improvement in oxygenation

    0-28 days

  • Incidence of nosocomial infections

    0-35 days

  • Incidence of hyperglycemia

    0-28 days

Study Arms (2)

Experimental Group

ACTIVE COMPARATOR

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

Placebo Group

PLACEBO COMPARATOR

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%)

Interventions

methylprednisoloneDRUG

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.

Experimental Group
Normal Saline (0.9%)DRUG

The placebo will be 0.9% (normal) saline and the active medication will be diluted in 0.9% (normal) saline.

Placebo Group

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Between 1 month and 18 years of age; AND
  • Admitted to the PICU with a diagnosis of ALI or ARDS, as defined by:
  • acute onset of the disease,
  • PaO2/FiO2 ratio \<300,
  • evidence of bilateral infiltrates on chest radiography, and
  • no evidence of cardiac dysfunction; AND
  • Intubated and mechanically ventilated.

You may not qualify if:

  • Underlying disease requiring steroids \>0.5mg/kg/day of methylprednisolone (eg. Asthma)
  • HIV positive, or have any other congenital or acquired immunodeficiency;
  • Terminally ill patients or patients on hospice care or if there is a lack of commitment to aggressive intensive care
  • Cytotoxic therapy within the past 3 weeks
  • Major gastrointestinal bleeding within last 1 month
  • Extensive burns (\>20% total body surface area of full- or partial-thickness burns)
  • Known or suspected adrenal insufficiency
  • Vasculitis or diffuse alveolar hemorrhage
  • Bone marrow or lung transplant
  • Disseminated fungal infections
  • Severe chronic liver disease
  • Other conditions with estimated 6-month mortality of 50% or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Related Publications (3)

  • Kimura D, Saravia J, Rovnaghi CR, Meduri GU, Schwingshackl A, Cormier SA, Anand KJ. Plasma Biomarker Analysis in Pediatric ARDS: Generating Future Framework from a Pilot Randomized Control Trial of Methylprednisolone: A Framework for Identifying Plasma Biomarkers Related to Clinical Outcomes in Pediatric ARDS. Front Pediatr. 2016 Mar 31;4:31. doi: 10.3389/fped.2016.00031. eCollection 2016.

    PMID: 27066464DERIVED

  • Schwingshackl A, Kimura D, Rovnaghi CR, Saravia JS, Cormier SA, Teng B, West AN, Meduri UG, Anand KJ. Regulation of inflammatory biomarkers by intravenous methylprednisolone in pediatric ARDS patients: Results from a double-blind, placebo-controlled randomized pilot trial. Cytokine. 2016 Jan;77:63-71. doi: 10.1016/j.cyto.2015.10.007. Epub 2015 Nov 3.

    PMID: 26545141DERIVED

  • Drago BB, Kimura D, Rovnaghi CR, Schwingshackl A, Rayburn M, Meduri GU, Anand KJ. Double-blind, placebo-controlled pilot randomized trial of methylprednisolone infusion in pediatric acute respiratory distress syndrome. Pediatr Crit Care Med. 2015 Mar;16(3):e74-81. doi: 10.1097/PCC.0000000000000349.

    PMID: 25634565DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Lung InjuryLung InjuryInflammationPneumonia

Interventions

MethylprednisoloneSaline Solution

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersThoracic InjuriesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfections

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2011

First Posted

January 11, 2011

Study Start

October 1, 2010

Primary Completion

January 1, 2014

Study Completion

December 1, 2014

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

US(1)