Inhaled Corticosteroids for Treatment of Bronchopulmonary Dysplasia

Related Clinical Trial
The Budesonide in Babies (BiB) Trial Follow-up Results of Newborns With Tracheostomy Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia Prolonged Outcomes After Nitric Oxide (PrONOx) A Study of Tobacco Smoke and Children With Respiratory Illnesses Delivery Room CPAP in Extremely Low Birth Weight Infants Dexamethasone Therapy in VLBW Infants at Risk of CLD Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children Estimating Length of Endotracheal Tube Insertion Using Gestational Age or Nasal-Tragus Length in Newborn Infants MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and Children Seattle-PAP Bubble Nasal CPAP and Work of Breathing High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Blood Oxygenation and Stability of Oxygenation Comparing Two Different Modes of Ventilation in Pretem Neonates Bilevel VG and PRVC High Frequency Ventilation in Premature Infants (HIFI) Early Caffeine in Preterm Neonates High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Lung Volume Monitored by Electric Tomography Impedance. Functional and Lymphocytic Markers of Respiratory Morbidity in Hyperoxic Preemies Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants Non-invasive Respiratory Support in Preterm Infants Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants. The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS Work of Breathing During Non-invasive Ventilation in Premature Neonates Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants Intratracheal Budesonide/Surfactant Prevents BPD Bronchopulmonary Disease (BPD) Patient Registry Premature Birth and Its Sequelae in Women Inhaled NO in Prevention of Chronic Lung Disease The Effects of Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome Continuous Versus Intermittent Bolus Feeding in Very Preterm Infants – Effect on Respiratory Morbidity Feasibility and Impact of Volume Targeted Ventilation in the Delivery Room Growth of Airways and Lung Tissues in Premature and Healthy Infants Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants Assessment of Lung Structure and Function of Infants Born Prematurely Post-hospitalization Nursing Effectiveness (PHONE) Study Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS) Neurotrophin Expression in Infants as a Predictor of Respiratory and Neurodevelopmental Outcomes Inhaled Beclomethasone to Prevent Chronic Lung Disease Work of Breathing in Premature Infants at Discharge Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome Hydrocortisone for BPD Clinic Features and Outcome of BPD (SGBPD) Neolifes Heart – Pulmonary Hypertension in Preterm Children Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia Management of Hyponatremia in Preterm Infants on Diuretics Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial Respiratory Outcome at Adolescence of Very Low Birthweight Infants Surfactant Administration During Spontaneous Breathing Determining the Effect of Spironolactone on Electrolyte Supplementation in Preterm Infants With Chronic Lung Disease Developmental Sequelae of Severe Chronic Lung Disorders Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study Indoor Air Quality and Respiratory Morbidity in School-Aged Children With BPD Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator Improving Prematurity-Related Respiratory Outcomes at Vanderbilt Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease – The AD-ON Study Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns Azithromycin in the Prevention of Lung Injury in Premature Newborn Randomized Control Trial: Synchronized Non-invasive Positive Pressure Ventilation Versus Non Synchronized Non Invasive Positive Pressure Ventilation in Extremely Low Birth Weight Infants Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation MRI in BPD Subjects A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease Early Versus Late Caffeine for ELBW Newborns Assessment of Lung Aeration at Birth MRI of Lung Structure and Function in Preterm Children BPD Saturation TARgeting Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD Antecedents of Bronchopulmonary Dysplasia Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood Aerosolized Albuterol Use in Severe BPD Late Sequelae of Bronchopulmonary Dysplasia Montelukast in Very Low Birthweight Infants Preterm Infant Inhaled Albuterol Dosing 129Xe MRI in Pediatric Population With BPD Investigation of Polymorphisms in Bronchopulmonary Dysplasia In Turkish Population Pulmonary MRI of Ex-preterm Children With and Without BPD To Understand Risk of Emphysematous Changes Comparison of Classification Standards of BPD in Premature Infants Inhaled Corticosteroids for Treatment of Bronchopulmonary Dysplasia Safety of Sildenafil in Premature Infants Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary Dysplasia Impact of an Exercise Program for Children Aged 4 to 6 Years With Bronchopulmonary Dysplasia Trial II of Lung Protection With Azithromycin in the Preterm Infant Forced Oscillometry in Infants With Bronchopulmonary Dysplasia The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia Fluid Filled Lung Oxygenation Assistance Trial Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia Risk Factors in Bronchopulmonary Dysplasia (Newborn Lung Project) Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants. Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia Physiologic Definition of Bronchopulmonary Dysplasia Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) – a US Study Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia Human Mesenchymal Stem Cells For Infants At High Risk For Bronchopulmonary Dysplasia SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants. Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD) Mesenchymal Stem Cells for The Treatment of Bronchopulmonary Dysplasia in Infants p16Ink4a in Bronchopulmonary Dysplasia in Children Transpyloric Feeding in Severe Bronchopulmonary Dysplasia Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia Phase 1 Intravenous Citrulline for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants Epidemiological Study for Bronchopulmonary Dysplasia (BPD) in China PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates Stem Cells for Bronchopulmonary Dysplasia Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia Interest of Pulmonary Ultrasound to Predict Evolution Towards Bronchopulmonary Dysplasia in Premature Infants at Gestational Age Less Than or Equal to 34 Weeks of Gestation Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD) Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia Study to Justify Steroid Use in Preterm Neonates to Prevent Bronchopulmonary Dysplasia Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia. Human Mesenchymal Stem Cells For Bronchopulmonary Dysplasia Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia

Brief Title

Inhaled Corticosteroids for Treatment of Bronchopulmonary Dysplasia

Official Title

A Dose-Ranging Study to Assess the Effect of Inhaled Corticosteroids in Ventilated Preterm Neonates

Brief Summary

      While many short-term morbidities associated with extreme prematurity have declined over the
      last two decades, the incidence of bronchopulmonary dysplasia (BPD) has increased to a rate
      of approximately 45% in neonates <28 weeks gestational age (GA) and birth weight (BW) <1,500
      g. Neonates with BPD are at increased risk for adverse short-and long-term neurodevelopmental
      and respiratory outcomes that often persist into adulthood.

      There is a growing body of pathological and biochemical evidence that implicates inflammation
      in its pathogenesis. This is further supported by randomized controlled trials (RCTs) that
      demonstrate the efficacy of systemic corticosteroids in facilitating extubation and reducing
      BPD. However, several short- and long-term adverse effects associated with the use of
      systemic corticosteroids have been described, the most concerning of which is their effect on
      neurodevelopment, specifically an increased rate of cerebral palsy (CP).

      Inhaled corticosteroids (ICS) are an attractive alternative to systemic steroids because of
      these concerns. Earlier systematic reviews had not found any benefit in using ICS for the
      prevention or treatment of BPD. However, a recent systematic review showed a significant
      reduction in death or BPD at 36 weeks' corrected GA (CGA) (risk ratio=0.86, 95% confidence
      interval 0.75, 0.99), BPD (RR=0.77, 95% CI 0.65, 0.91), and use of systemic steroids
      (RR=0.87, 95% CI 0.76, 0.98) in infants treated with ICS.

      Despite growing evidence of the effectiveness of ICS for BPD, uncertainty remains over
      treatment timing, effective dose, and long-term effects. There is also variation in the
      delivery systems used for delivery of ICS. These concerns continue to be echoed in a recent
      review by Nelin et al. Given that the long-term neurodevelopmental impact of ICS were unknown
      at the time of this study and many infants are able to wean from ventilation without
      steroids, the investigators conducted an escalating-dose ranging study of late ICS (i.e.
      administered after the first week of life) delivered by a metered dose inhaler (MDI)
      utilizing a specially designed valved delivery system to determine the minimum effective dose
      necessary to achieve extubation or reduction in oxygen requirements and the long-term
      neurodevelopmental impact of increasing doses of ICS.
    

Detailed Description

      Research Question:

      What is the effective dose of inhaled steroids (HFA-BDP) in ventilated preterm infants?
      Material and Methods Objective: The primary purpose of this study is to determine the optimal
      dose of inhaled steroids (using HFA-BDP) in ventilated preterm infants. The result from this
      study will determine the dose of inhaled steroids to be used for a subsequent randomized
      placebo-controlled trial with sufficient power to determine if inhaled steroid is associated
      with reduction in CLD in ventilated preterm infants without any detrimental effect on long
      term neurodevelopmental outcome.

      Study Design: Escalating dose-ranging study Study Population: Babies with birth weights <
      1,250 grams and gestational age < 32 weeks admitted in the NICU at Sunnybrook and Women's
      College Health Sciences Centre and Mount Sinai Hospital Inclusion Criteria: Birth weight <
      1,250 grams and gestational age < 32 weeks, Need for assisted mechanical ventilation
      (ventilation rate > 15 breaths/min, and fractional oxygen concentration of inspired gas
      (Fio2) > 0.3 but < 0.6), Postnatal age 10-21 days, Stable ventilatory requirements over the
      48-72 hours prior to enrollment Exclusion Criteria: Actual or suspected sepsis, Congenital
      cardiorespiratory malformation, Patent ductus arteriosus, Presence of necrotizing
      enterocolitis, gastrointestinal hemorrhage or perforation, Treatment with systemic
      dexamethasone Duration of therapy: 7 days Drug Regimen: Groups of neonates will be treated
      with an escalating dose of HFA-BDP until either efficacy equal to that seen with
      dexamethasone or significant side-effects are observed. 10 neonates will be treated at each
      dosage level before moving up to the next dose. Each neonate will be treated with only one
      dose.

      Bowser et al have performed an in vitro evaluation of drug deposition of HFA-BDP (QVAR*) and
      CPC-BDP MDI (Beclovent) via an aerosol delivery chamber (Aerochamber) and endotracheal tube
      (uncuffed Portex 3.5, 3.0 and 2.5) at low tidal volumes. The PARI Compas Breath Simulator was
      used to simulate neonatal and infant respiratory cycles. For both formulations and all
      endotracheal tubes, the output (*g) increased significantly at the tidal volume and
      inspiratory flow rates were increased. The 3.5 endotracheal tube side gave greater
      output/puff at all tidal volumes and for both formulations as compared to the smaller
      endotracheal tubes. Greater in vitro deposition was measured for QVAR than for beclovent,
      possibly leading to greater in vivo delivery to the lung of this new HFA-BDP MDI formulation
      to intubated infants

      Thus, for the purpose of this study Beclomethasone Dipropionate (HFA-BDP, QVAR*) in the
      following doses will be evaluated:

        1. 200 *g bid

        2. 400 *g bid

        3. 600 *g bid

        4. 800 *g bid Inhaled steroids will be administered using a specially designed neonatal
           aerosol delivery system manufactured by Trudell Canada (see diagram, Appendix I). The
           device will be connected directly to the endotracheal tube on one side with the
           ventilator circuit on the other. The ventilator settings will be temporarily adjusted to
           achieve an expiratory tidal volume of 7ml/kg (based on birth weight) and a rate of 30
           breaths/min and an inspiratory time of 0.5 seconds. There will be a one-minute interval
           between each actuation from the MDI. Continuous cardiac and oxygen saturation monitoring
           will be used throughout the treatment period. One-minute after the final puff has been
           administered, the delivery system will be removed and the baby returned to the
           ventilator settings previously used. The total daily dose will be administered in two
           divided doses.

      If the infant is extubated during the study period administration of inhaled medications will
      be stopped.

      Outcome Measures - Efficacy Primary Outcome: Reduction in Fio2 from the 2 days prior to
      treatment to the final 2 days of the study period or extubation during the study period.
      Extubation is considered to be successful if the infant does not require assisted ventilation
      in the next 48 hours. A reduction in additional Fio2 of 75% or greater will be considered a
      significant improvement (i.e. a baby with a baseline Fio2 of 0.51 who requires less than 0.28
      [0.21 + 0.25 (0.51-0.21)] at the end of the treatment period will be considered a treatment
      success).

      Secondary Outcome:

      Ventilatory status: Ventilator rate Mean airway pressure Peak inspiratory pressure
      Ventilatory parameters will be assessed at the same time intervals as Fio2 described above.

      Adverse Event Monitoring Each patient will be carefully monitored for adverse events by the
      investigators. The following events will be specifically monitored.

        1. Hypertension: Blood pressure (BP) will be noted every 12 hourly using an automatic
           sphygmomanometer (Dinamap, Criticon Inc.). Hypertension is defined as BP higher than 2
           SD above the mean for the infant's gestational and postnatal age.

        2. Hyperglycemia: Urine and blood glucose will be monitored as per nursing standard
           protocol for infants who are on steroids. Hyperglycemia will be defined as a blood
           glucose > 10 *mol/L.

        3. Growth: Weight and head circumference will be recorded prior to and after completion of
           the study period.

        4. Infection: Sepsis is defined as a need for antibiotic therapy because of a positive
           blood or cerebrospinal fluid culture or clinical diagnosis of pneumonia.

        5. Evidence of feeding intolerance, necrotizing enterocolitis or intestinal perforation
           will be noted.

        6. Candidiasis of the mouth and throat will be noted. Assessment will be made of the
           seriousness, intensity and relationship to the administration of the study medication.
           If, in the opinion of the investigator, the adverse event is not tolerated, the patient
           will be withdrawn from the study and monitored until resolution of the adverse event or
           until a conclusion is reached as to its irreversible nature.

      Suppression of the hypothalamic-pituitary-adrenal axis (HPA):

      Adrenal suppression is an important adverse effect, which occurs during glucocorticoid
      therapy (particularly when administered systemically). Controversy exists regarding the
      variable effect of glucocorticoid therapy on the immature HPA axis. The dose and duration of
      therapy, methodology and timing of adrenal function assessment and inter-patient variablity
      influence the degree and duration of suppression. Also, there is no consensus regarding
      normal HPA function in extremely premature infant. Therefore, for the purpose of this pilot
      study where the drug is administered for a very short duration the HPA axis will not be
      investigated. Assessment of the HPA axis will be part of the larger randomized controlled
      trial.

      Laboratory test abnormalities considered by the Investigator to be clinically relevant will
      be reported on the Adverse Event Page of the CRF.

      Adverse events and laboratory test abnormalities fulfilling the definition of "serious" must,
      in addition, be reported in detail on the Serious Adverse Event Form.

      Signs and symptoms of each AE should be described in detail: start and stop dates, intensity,
      relationship it investigational product, action taken and outcome.

      Safety Assessment Adverse events will be tracked as described below. After each serious AE,
      the safety monitoring committee will be informed and will investigate the relationship
      between the AE and study drug administration. Any time a serious AE is felt to be "probably
      related" to the therapy, consideration will be given to stopping the study. If a series of
      serious AE events are felt to be "possibly related" or a series of minor events felt to be
      "probably related" to treatment with the study drug, the study may also be stopped. The REB,
      3M pharmaceuticals and HPB will be kept informed of all such deliberations. The members of
      the safety committee include Dr. Arne Ohlsson, Director Evidence Based Neonatal Care and
      Outcomes Research, MSH, Dr. Elizabeth Asztalos, Staff Neonatologist, SWCHSC and Joseph
      Beyene, Biostatistician, MSH. After enrollment of 10 neonates at a particular dosing level
      the safety committee will be requested to review the data for efficacy and safety. If no
      benefit or no significant adverse events are noted then the decision will be made to move to
      the next dosing level.

      Weaning Protocol Respiratory therapists will use set criteria for weaning from ventilation.
      For 48 hours prior to commencement of treatment, a record will be made of the baseline
      ventilator settings. A transcutaneous pCO2 monitor will be applied daily for the duration of
      the study. Blood gases (capillary or arterial) will be performed as clinically indicated: ie.
      in response to changes in clinical status, oxygen requirements (oxygen saturation) or
      transcutaneous pCO2. Supplemental oxygen and ventilation will be adjusted to maintain an
      oxygen saturation of 90-95%, carbon dioxide tension between 45-60mm Hg (5.8-7.8 KPA) and a
      blood pH of at least 7.25. If clinically indicated, the proximal airway pressure will be
      reduced in decrements of 2mm Hg until a mean airway pressure of 8mm Hg is reached, following
      which the ventilator rate will be reduced in decrements of 2-5 breaths/min until a rate of
      10-12 breaths/min is achieved. Neonates will be extubated from a rate of 10-12 breaths/min a
      mean airway pressure of 8mm Hg and Fio2 concentration of < 0.3. A record will be made of the
      need for nasal CPAP following extubation.

      Sample size estimation The study design is an escalating dose ranging study with an aim to
      identify both an effective and a safe dose of inhaled steroids. 10 babies will be enrolled in
      each dose category. The study will be stopped if the therapeutic efficacy is achieved in a
      given dosage group or if significant side effects are noted. Therapeutic efficacy will be
      considered to have occurred in a group of 6 or more babies out of 10 meet the primary outcome
      [based upon response expected with dexamethasone therapy - data from Ohlsson et al
      (Unpublished data from MSc thesis)].

      Statistical Analysis Analysis of variance for repeated measures will be used to assess the
      effect of therapy over time in each dosage group. This analysis will be applied to Fio2 and
      ventilatory parameters
    


Study Type

Interventional


Primary Outcome

Reduction in FiO2 > 75%

Secondary Outcome

 Ventilator rate (breaths per minute)

Condition

Bronchopulmonary Dysplasia

Intervention

Inhaled Beclomethasone Dipropionate Monohydrate

Study Arms / Comparison Groups

 Drug
Description:  Patients receiving inhaled beclomethasone diproprionate in four escalating doses:
200 mcg bid
400 mcg bid
600 mcg bid
800 mcg bid

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

41

Start Date

July 27, 2001

Completion Date

November 15, 2006

Primary Completion Date

November 15, 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Birth weight < 1,250 grams

          -  Gestational age < 32 weeks

          -  Need for assisted, invasive mechanical ventilation with at least the following
             settings:

        ventilation rate > 15 breaths per min, fractional oxygen concentration of inspired gas
        (FiO2) > 30% but < 60%)

          -  Postnatal age 10-21 days

          -  Stable ventilatory requirements over the 48-72 hours prior to enrollment

        Exclusion Criteria:

          -  Actual or suspected sepsis

          -  Congenital cardiorespiratory malformation

          -  Patent ductus arteriosus

          -  Presence of necrotizing enterocolitis

          -  Presence of gastrointestinal hemorrhage or perforation

          -  Treatment with systemic dexamethasone
      

Gender

All

Ages

N/A - 4 Weeks

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT03503994

Organization ID

2000/363


Responsible Party

Principal Investigator

Study Sponsor

Mount Sinai Hospital, Canada

Collaborators

 Sunnybrook Health Sciences Centre

Study Sponsor

, , 


Verification Date

April 2018