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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD); Prospective, Double Blind, Randomized Placebo-control,

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.

Detailed Summary:
Sponsor: Bnai Zion Medical Center

Current 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. [ Time Frame: 4 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical outcomes at each visit [ Time Frame: 4 months ]

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.


Original Secondary Outcome: Same as current

Information By: Bnai Zion Medical Center

Dates:
Date Received: June 13, 2011
Date Started: June 2011
Date Completion: June 2016
Last Updated: August 11, 2015
Last Verified: August 2015