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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bronchopulmonary Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Inhaled QVAR

Inhaled QVAR 100 mic via aerochamber twice daily until 3 month post discharge

Group Type EXPERIMENTAL

Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)

Intervention Type DRUG

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.

Inhaled placebo

Inhaled nonmedicated MDI \[metered dose inhaler\] in a similarly marked aerosol chamber using the same delivery technique, obtained from the drug manufacturer

Group Type PLACEBO_COMPARATOR

Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)

Intervention Type DRUG

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.

Interventions

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Inhaled 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

3 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No