Frontiers in pediatrics · 2026
Inhaled budesonide and beclomethasone for the prevention and treatment of bronchopulmonary dysplasia in very preterm infants: a prospective randomized controlled trial.
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Wang Bingjie, Xu Siyuan, Li Zheng, Yang Kaidong, Xu Nuo, Huang Di, Zhao Dandan, Yang Bo, Gao Xiangyu
Аннотация
BACKGROUND: To investigate the clinical efficacy and safety of inhaled budesonide and beclomethasone for the prevention and treatment of bronchopulmonary dysplasia (BPD) in very preterm infants.
METHODS: From October 2024 to November 2025, very preterm infants at high risk of BPD, aged >7 days and still requiring non-invasive respiratory support, who were admitted to the Neonatal Intensive Care Unit of Xuzhou Central Hospital, were selected and randomly divided into three groups. The control group received inhaled normal saline at a dose of 1 mL per administration, once every 12 h (q 12 h); the budesonide group received inhaled budesonide at a dose of 0.5 mg per administration, q 12 h; the beclomethasone group received inhaled beclomethasone at a dose of 0.4 mg per administration, q 12 h. Inhalation treatment was continued in all three groups until respiratory support was no longer needed. The total duration of respiratory support, the incidence and severity of BPD, the incidence of adverse outcomes, and inflammatory markers were compared among the three groups. Multivariate Logistic regression analysis was used to identify the independent risk factors and protective factors for BPD in very preterm infants.
RESULTS: Finally, 37 cases were enrolled in the control group, 41 cases in the budesonide group, and 40 cases in the beclomethasone group. The total duration of respiratory support and length of hospital stay in the budesonide group (36.4 ± 14.9 d, 39.5 ± 10.1 d) and the beclomethasone group (35.6 ± 15.1 d, 39.8 ± 11.0 d) were shorter than those in the control group (43.5 ± 13.5 d, 50.4 ± 8.5 d), with statistically significant differences (P < 0.05). There were no statistically significant differences among the three groups in terms of the incidence of BPD, the incidence of mild and moderate-severe BPD, the mean values of fraction of inspired oxygen and oxygen saturation index within 48 h after initiation of treatment, the incidence of late-onset sepsis, stage Ⅱ-Ⅲ necrotizing enterocolitis, grade Ⅱ-Ⅳ intraventricular hemorrhage, the incidence of treatment-requiring retinopathy of prematurity at initial screening, the volume of packed red blood cell transfusion, hemodynamically significant patent ductus arteriosus at discharge, and hospitalization costs (P > 0.05). On the 14th day after treatment initiation, the levels of interleukin-8 were lower and the levels of interleukin-10 were higher in both the budesonide group and the beclomethasone group than those in the control group, with statistically significant differences (P < 0.05). There were no statistically significant differences in any of the indicators between the budesonide group and the beclomethasone group (P > 0.05). Younger gestational age and lower birth weight were identified as independent risk factors for BPD in very preterm infants, whereas inhaled budesonide or beclomethasone administration after the first week of life served as independent protective factors against BPD.
CONCLUSIONS: Inhaled budesonide and beclomethasone after the first week of life can shorten the total duration of respiratory support in very preterm infants at high risk of BPD, aged > 7 days and still require non-invasive respiratory support, without increasing the incidence of adverse outcomes, demonstrating high safety. However, inhaled budesonide and beclomethasone do not show significant advantages in reducing the incidence and severity of BPD.
CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/bin/project/edit?pid=248724, identifier ChiCTR2400091361.
METHODS: From October 2024 to November 2025, very preterm infants at high risk of BPD, aged >7 days and still requiring non-invasive respiratory support, who were admitted to the Neonatal Intensive Care Unit of Xuzhou Central Hospital, were selected and randomly divided into three groups. The control group received inhaled normal saline at a dose of 1 mL per administration, once every 12 h (q 12 h); the budesonide group received inhaled budesonide at a dose of 0.5 mg per administration, q 12 h; the beclomethasone group received inhaled beclomethasone at a dose of 0.4 mg per administration, q 12 h. Inhalation treatment was continued in all three groups until respiratory support was no longer needed. The total duration of respiratory support, the incidence and severity of BPD, the incidence of adverse outcomes, and inflammatory markers were compared among the three groups. Multivariate Logistic regression analysis was used to identify the independent risk factors and protective factors for BPD in very preterm infants.
RESULTS: Finally, 37 cases were enrolled in the control group, 41 cases in the budesonide group, and 40 cases in the beclomethasone group. The total duration of respiratory support and length of hospital stay in the budesonide group (36.4 ± 14.9 d, 39.5 ± 10.1 d) and the beclomethasone group (35.6 ± 15.1 d, 39.8 ± 11.0 d) were shorter than those in the control group (43.5 ± 13.5 d, 50.4 ± 8.5 d), with statistically significant differences (P < 0.05). There were no statistically significant differences among the three groups in terms of the incidence of BPD, the incidence of mild and moderate-severe BPD, the mean values of fraction of inspired oxygen and oxygen saturation index within 48 h after initiation of treatment, the incidence of late-onset sepsis, stage Ⅱ-Ⅲ necrotizing enterocolitis, grade Ⅱ-Ⅳ intraventricular hemorrhage, the incidence of treatment-requiring retinopathy of prematurity at initial screening, the volume of packed red blood cell transfusion, hemodynamically significant patent ductus arteriosus at discharge, and hospitalization costs (P > 0.05). On the 14th day after treatment initiation, the levels of interleukin-8 were lower and the levels of interleukin-10 were higher in both the budesonide group and the beclomethasone group than those in the control group, with statistically significant differences (P < 0.05). There were no statistically significant differences in any of the indicators between the budesonide group and the beclomethasone group (P > 0.05). Younger gestational age and lower birth weight were identified as independent risk factors for BPD in very preterm infants, whereas inhaled budesonide or beclomethasone administration after the first week of life served as independent protective factors against BPD.
CONCLUSIONS: Inhaled budesonide and beclomethasone after the first week of life can shorten the total duration of respiratory support in very preterm infants at high risk of BPD, aged > 7 days and still require non-invasive respiratory support, without increasing the incidence of adverse outcomes, demonstrating high safety. However, inhaled budesonide and beclomethasone do not show significant advantages in reducing the incidence and severity of BPD.
CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/bin/project/edit?pid=248724, identifier ChiCTR2400091361.