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

Bnai Zion Medical Center60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Bronchopulmonary Dysplasia

Interventions

Eligibility

Sex: ALLMin age: 3 WeeksMax age: 12 Weeks

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Clinical outcomes at each visit

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.