Trial of Steroids in Pediatric Acute Lung Injury/ARDS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Justify Steroid Use in Preterm Neonates to Prevent Bronchopulmonary Dysplasia

NCT03035214

Bronchopulmonary Dysplasia

UNKNOWN PHASE2

Drug Study of Albuterol to Treat Acute Lung Injury

NCT00434993

Respiratory Distress Syndrome, Adult

TERMINATED PHASE2/PHASE3

Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome

NCT04064684

Acute Respiratory Distress Syndrome

TERMINATED PHASE2

Ideal Steroids for Asthma Treatment in the PICU

NCT03900624

Asthma Childhood

COMPLETED PHASE4

Paediatric Ards Neuromuscular Blockade Study

NCT02902055

ARDS

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

methylprednisolone

Intervention Type DRUG

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 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.

Group Type PLACEBO_COMPARATOR

Normal Saline (0.9%)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No