Bronchopulmonary Dysplasia
Conditions
Keywords
Inhaled steroids, bronchopulmonary dysplasia, Infants with moderate to severe BPD
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.
Interventions
DRUGInhaled 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.
Sponsors
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
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 12 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes at each visit | 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. |
Countries
Israel
Contacts
Primary ContactAmir Kugelman, MD
Outcome results
None listed