Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD)
This study is currently recruiting participants.
Verified June 2011 by Bnai Zion Medical Center
Sponsor:
Bnai Zion Medical Center
Collaborators:
Tel-Aviv Sourasky Medical Center
Schneider Children's Medical Center, Israel
Meir Hospital, Kfar Saba, Israel
Kaplan Medical Center
Barzilai Medical Center
Laniado Hospital
HaEmek Medical Center, Israel
Information provided by (Responsible Party):
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT01373008
First received: June 13, 2011
Last updated: February 5, 2013
Last verified: June 2011
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Purpose
Premature infants with chronic lung disease (bronchopulmonary dysplasia [BPD]) are commonly treated with inhaled steroids, an optional treatment according to textbooks and guidelines . However, the evidence supporting this treatment in spontaneously breathing infants is limited, and based on only two randomized, placebo-controlled trials (RCT) with relative small number of infants . The Cochrane review concluded that these studies do not allow firm conclusions with regard to the efficacy of inhaled steroids in non-ventilated infants . Thus, there is no doubt that there is a need for more RCT in order to ascertain the role of inhaled steroids in infants with BPD. Because of its physical properties that theoretically make QVAR an attractive therapy in infants and studies showing it to be as effective as and with similar safety profile as other inhaled steroids in children, the investigators hypothesized that inhaled QVAR will be an effective therapy in infants with BPD.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchopulmonary Dysplasia |
Drug: Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD); Prospective, Double Blind, Randomized Placebo-control, Multi-center Study |
Resource links provided by NLM:
Further study details as provided by Bnai Zion Medical Center:
Primary Outcome Measures:
- The primary outcome will be to compare the rate of readmissions to the hospital for BPD exacerbation during the study period between infants treated with QVAR vs. placebo. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical outcomes at each visit [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]During each visit the following parameters will be charted: Date, vital signs (heart rate, respiratory rate, blood pressure, oxygen pulse oximetry) and physical examination (respiratory distress [0-none, 2- mild, 5-severe], wheezing [0-none, 2- mild, 5-severe], crepitations [0-none, 2- mild, 5-severe]). Will check growth, oxygen need, and in some infant adrenal suppression by urine examination.
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Inhaled QVAR
Inhaled QVAR 100 mic via aerochamber twice daily until 3 month post discharge
|
Drug: Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)
Infants will be randomized for Inhaled QVAR 100 microgram or placebo twice daily with spontaneous tidal breathing for 30 seconds via aerochamber with face mask for the study period.
|
|
Placebo Comparator: Inhaled placebo
Inhaled nonmedicated MDI [metered dose inhaler] in a similarly marked aerosol chamber using the same delivery technique, obtained from the drug manufacturer
|
Drug: Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)
Infants will be randomized for Inhaled QVAR 100 microgram or placebo twice daily with spontaneous tidal breathing for 30 seconds via aerochamber with face mask for the study period.
|
Eligibility| Ages Eligible for Study: | up to 12 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Preterm infants with moderate to severe BPD, defined as oxygen <30%, or >30% or with positive pressure support at 36 weeks corrected gestational age, respectively
- Parents signed an informed consent
- The parents will comply with the 3 months study follow-up requirements, as judged by the site principal investigator.
Exclusion Criteria:
- Congenital malformation
- Cardiac disease (including active PDA)
- Intraventricular hemorrhage grade III-IV
- Unstable conditions such as sepsis, apneas, ets. at time of enrollment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373008
Contacts
| Contact: Amir Kugelman, MD | 972-4-8359063 | amirkug@gmail.com |
Locations
| Israel | |
| Bnai Zion Medical Center | Recruiting |
| Haifa, Israel, 31048 | |
| Principal Investigator: Amir Kugelman, MD | |
Sponsors and Collaborators
Bnai Zion Medical Center
Tel-Aviv Sourasky Medical Center
Schneider Children's Medical Center, Israel
Meir Hospital, Kfar Saba, Israel
Kaplan Medical Center
Barzilai Medical Center
Laniado Hospital
HaEmek Medical Center, Israel
More Information
No publications provided
| Responsible Party: | Bnai Zion Medical Center |
| ClinicalTrials.gov Identifier: | NCT01373008 History of Changes |
| Other Study ID Numbers: | 0110-10 |
| Study First Received: | June 13, 2011 |
| Last Updated: | February 5, 2013 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Bnai Zion Medical Center:
|
Inhaled steroids bronchopulmonary dysplasia Infants with moderate to severe BPD |
Additional relevant MeSH terms:
|
Bronchopulmonary Dysplasia Hyperplasia Ventilator-Induced Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Pathologic Processes Beclomethasone |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 19, 2013