Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD)

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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

N/A - 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