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Trial record 1 of 1 for:    NCT03503994
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Inhaled Corticosteroids for Treatment of Bronchopulmonary Dysplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03503994
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sunnybrook Health Sciences Centre
IWK Health Centre
Information provided by (Responsible Party):
Vibhuti Shah, Mount Sinai Hospital, Canada

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.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Drug: Inhaled Beclomethasone Dipropionate Monohydrate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose-Ranging Study to Assess the Effect of Inhaled Corticosteroids in Ventilated Preterm Neonates
Actual Study Start Date : July 27, 2001
Actual Primary Completion Date : November 15, 2006
Actual Study Completion Date : November 15, 2006

Arm Intervention/treatment

Patients receiving inhaled beclomethasone diproprionate in four escalating doses:

  1. 200 mcg bid
  2. 400 mcg bid
  3. 600 mcg bid
  4. 800 mcg bid
Drug: Inhaled Beclomethasone Dipropionate Monohydrate

Beclomethasone Dipropionate (HFA-BDP, QVAR*) in the following doses will be evaluated:

  1. 200 mcg bid
  2. 400 mcg bid
  3. 600 mcg bid
  4. 800 mcg bid

Primary Outcome Measures :
  1. Reduction in FiO2 > 75% [ Time Frame: 1 week per dose ]
    Reduction in FiO2 (%) from the 2 days prior to treatment to the final 2 days of the study period. A reduction in additional FiO2 of 75% or greater will be considered a significant improvement. For example, a baby with a baseline FiO2 of 51% would have a significant reduction in FiO2 if post-treatment FiO2 is less than 0.28 using the following calculation: FiO2 reduction 75% = [0.21 + 0.25 (0.51-0.21)]

  2. Successful extubation [ Time Frame: 1 week per dose ]
    Extubation during the study period is considered to be successful if the infant does not require assisted, invasive ventilation for at least 48 hours after the removal of the endotracheal tube and is extubated during the treatment period.

Secondary Outcome Measures :
  1. Ventilator rate (breaths per minute) [ Time Frame: 1 week ]
    Ventilator rate (breaths per minute) at the end of treatment

  2. Mean airway pressure (cm H2O) [ Time Frame: 1 week ]
    The mean airway pressure (cm H2O) required by the baby at the end of treatment

  3. Peak inspiratory pressure (cm H2O) [ Time Frame: 1 week ]
    The peak inspiratory pressure (cm H2O) required by the baby at the end of treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Vibhuti Shah, Staff Neonatologist, Mount Sinai Hospital, Canada Identifier: NCT03503994    
Other Study ID Numbers: 2000/363
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents