OBJECTIVE: Inflammation plays an important role in the development of chronic lung disease (CLD), which has become a major cause of morbidity in surviving infants less than 1250 g at birth. The authors hypothesized that the progression of this inflammation and, therefore, the establishment of CLD would be decreased with the use of early prophylactic inhaled corticosteroids. Short, and long term respiratory and neurodevelopmental outcomes were also examined. DESIGN: A double-blind, randomized placebo controlled trial. SETTING: Level-III neonatal intensive care unit. POPULATION STUDIED: Sixty infants less than 1250 g at birth, diagnosed with respiratory distress syndrome and requiring ventilatory support at 72 h of age were enrolled in the study. INTERVENTION: Infants enrolled received either placebo or beclomethasone diproprionate by a metered dose inhaler, which was used in-line with the ventilator circuit while the infant was ventilated and then via a spacer until 28 days of age. RESULTS:Thirty infants were givenbeclomethasone and 30 were given placebo. There were two deaths in each group. Among the surviving infants, the frequency of moderate-to-severe CLD was 17% in each study group. Mean time to extubation was not different for beclomethasone compared with placebo at 16.4 and 12.5 days (P=0.12), respectively. The requirement for intravenous corticosteroids was lower in the beclomethasone-treated group (RR 0.67, 95% CI 0.43 to 1.04), although this difference was not statistically significant. The incidence of growth failure, infection and intraventricular hemmorhage did not differ between the two groups. Long term outcomes were not different with respect to the incidence of respiratory re-admissions, cerebral palsy, developmental delay, blindness or deafness. CONCLUSIONS: Early treatment with inhaled beclomethasone diproprionate did not reduce the incidence of CLD or decrease the duration of mechanical ventilation. The decrease in intravenous corticosteroid use was not statistically significant. Long term outcome was not affected.
RCT Entities:
OBJECTIVE:Inflammation plays an important role in the development of chronic lung disease (CLD), which has become a major cause of morbidity in surviving infants less than 1250 g at birth. The authors hypothesized that the progression of this inflammation and, therefore, the establishment of CLD would be decreased with the use of early prophylactic inhaled corticosteroids. Short, and long term respiratory and neurodevelopmental outcomes were also examined. DESIGN: A double-blind, randomized placebo controlled trial. SETTING: Level-III neonatal intensive care unit. POPULATION STUDIED: Sixty infants less than 1250 g at birth, diagnosed with respiratory distress syndrome and requiring ventilatory support at 72 h of age were enrolled in the study. INTERVENTION: Infants enrolled received either placebo or beclomethasone diproprionate by a metered dose inhaler, which was used in-line with the ventilator circuit while the infant was ventilated and then via a spacer until 28 days of age. RESULTS: Thirty infants were given beclomethasone and 30 were given placebo. There were two deaths in each group. Among the surviving infants, the frequency of moderate-to-severe CLD was 17% in each study group. Mean time to extubation was not different for beclomethasone compared with placebo at 16.4 and 12.5 days (P=0.12), respectively. The requirement for intravenous corticosteroids was lower in the beclomethasone-treated group (RR 0.67, 95% CI 0.43 to 1.04), although this difference was not statistically significant. The incidence of growth failure, infection and intraventricular hemmorhage did not differ between the two groups. Long term outcomes were not different with respect to the incidence of respiratory re-admissions, cerebral palsy, developmental delay, blindness or deafness. CONCLUSIONS: Early treatment with inhaled beclomethasone diproprionate did not reduce the incidence of CLD or decrease the duration of mechanical ventilation. The decrease in intravenous corticosteroid use was not statistically significant. Long term outcome was not affected.
Entities:
Keywords:
Chronic lung disease; Clinical trial; Growth delay; Inhaled corticosteroid; Long term neurodevelopmental follow-up; Randomized control trial
Authors: T M O'Shea; J M Kothadia; K L Klinepeter; D J Goldstein; B G Jackson; R G Weaver; R G Dillard Journal: Pediatrics Date: 1999-07 Impact factor: 7.124
Authors: R A Sinkin; H S Dweck; M J Horgan; K J Gallaher; C Cox; W M Maniscalco; P R Chess; C T D'Angio; R Guillet; J W Kendig; R M Ryan; D L Phelps Journal: Pediatrics Date: 2000-03 Impact factor: 7.124
Authors: J J Zimmerman; D Gabbert; C Shivpuri; S Kayata; W Ciesielski; J Miller; M E Peters; R P Eissenstat; G Shen Journal: Am J Perinatol Date: 1998 Impact factor: 1.862