Brief Title
Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD)
Official Title
Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD); Prospective, Double Blind, Randomized Placebo-control, Multi-center Study
Brief Summary
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
Clinical outcomes at each visit
Condition
Bronchopulmonary Dysplasia
Intervention
Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)
Study Arms / Comparison Groups
Inhaled QVAR
Description: Inhaled QVAR 100 mic via aerochamber twice daily until 3 month post discharge
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
60
Start Date
June 2011
Completion Date
June 2016
Primary Completion Date
June 2016
Eligibility Criteria
Inclusion Criteria:
1. 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
2. Parents signed an informed consent
3. The parents will comply with the 3 months study follow-up requirements, as judged by
the site principal investigator.
Exclusion Criteria:
1. Congenital malformation
2. Cardiac disease (including active PDA)
3. Intraventricular hemorrhage grade III-IV
4. Unstable conditions such as sepsis, apneas, ets. at time of enrollment.
Gender
All
Ages
3 Weeks - 12 Weeks
Accepts Healthy Volunteers
No
Contacts
, 972-4-8359063, [email protected]
Location Countries
Israel
Location Countries
Israel
Administrative Informations
NCT ID
NCT01373008
Organization ID
0110-10
Responsible Party
Sponsor
Study Sponsor
Bnai Zion Medical Center
Collaborators
Tel-Aviv Sourasky Medical Center
Study Sponsor
, ,
Verification Date
August 2015