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JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

Meter-dosed, inhaled beclomethasone initiated at birth to prevent bronchopulmonary dysplasia

J J Zimmerman, D Gabbert, C Shivpuri, S Kayata, J Miller, W Ciesielski
Pediatric Critical Care Medicine 2000, 1 (2): 140-5
12813265

OBJECTIVE: To examine the hypothesis that meter-dosed, inhaled beclomethasone administered to premature infants, beginning at birth and continuing in a tapering dosage schedule over the first 12 days of life, decreases the occurrence of bronchopulmonary dysplasia (BPD), at 36 wks corrected gestational age.

DESIGN: Prospective, randomized, double-blind, placebo-controlled, small pilot clinical trial.

SETTING: Tertiary care, neonatal intensive care unit.

PATIENTS: Premature low birth weight neonates (<or=1300 g) followed from birth until 36 wks corrected gestational age.

INTERVENTIONS: Aerosolized beclomethasone dipropionate was administered in a tapering dosage schedule beginning at birth and extended for the first 12 days of life, utilizing an aerosol spacer chamber and manual hand ventilation. In a subset of the subjects, a cosyntropin stimulation test was conducted on day 13 to ascertain potential hypothalamic-pituitary-adrenal axis suppression. Need for mechanical ventilation/continuous positive airway pressure (CPAP) and/or oxygen was assessed at 30 days of life and 36 wks corrected gestational age in addition to a number of other variables clinically relevant to the development of BPD.

MEASUREMENTS AND MAIN RESULTS: In total, 19 placebo-treated and 20 beclomethasone-treated infants completed the study. Inhaled beclomethasone significantly reduced the need for supplemental oxygen at 30 days (p =.005) of life but not at 36 wks corrected gestational age (p =.243). A significantly greater proportion of infants receiving beclomethasone were extubated before 2 wks of age (p =.035), and infants receiving beclomethasone required significantly fewer days of mechanical ventilation (p =.004), but increased days of nasal CPAP as compared with the control group. Although fewer beclomethasone-treated than placebo-treated infants were administered intravenous steroids after 2 wks of age, this difference was not significant. No differences between groups were noted for the diagnoses of retinopathy of prematurity, nosocomial infection, or intraventricular hemorrhage. Similarly, no differences in the cosyntropin stimulation test were ascertained between treated and nontreated infants. No adverse effects were attributable to inhaled beclomethasone.

CONCLUSIONS: In this small series, inhaled beclomethasone initiated at birth did not reduce the occurrence of BPD as defined by the continued requirement for supplemental oxygen at 36 wks corrected gestational age. However, inhaled beclomethasone did reduce the need for supplemental oxygen at 30 days of life and appeared to facilitate the transition from intubation/mechanical ventilation to less invasive nasal CPAP, as demonstrated by more frequent extubation before 2 wks of age and decreased total duration of mechanical ventilation in the beclomethasone-treated group. No adverse effects, including adrenal suppression, were noted in infants treated with inhaled beclomethasone. On the basis of the safety and apparent effectiveness of early inhaled beclomethasone in reducing the need for invasive mechanical ventilation and supplemental oxygen during the first month of life in premature infants, a larger clinical trial with greater power is warranted to ascertain if early inhaled beclomethasone can attenuate the occurrence of BPD.

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