Objective We hypothesised that a prophylactic inhaled steroid would prevent the progression of bronchopulmonary dysplasia (BPD) in extremely low birthweight infants (ELBWIs).
Design This study was a multicentre, randomised, double-blinded, placebo-controlled trial.
Setting This investigation was conducted in 12 level III neonatal intensive care units (NICUs).
Patients A total of 211 ELBWIs requiring ventilator support were enrolled.
Intervention Starting within 24 h of birth and continuing until 6 weeks of age or extubation, two doses of 50 μg fluticasone propionate (FP) or placebo were administered every 24 h.
Main outcome measurement The primary outcome measure used to indicate the morbidity of severe BPD incidence was death or oxygen dependence at discharge from the NICU. The secondary measures were neurodevelopmental impairments (NDIs) at 18 months of postmenstrual age and 3 years of age. We performed subgroup analyses based on gestational week (GW) and the presence of chorioamnionitis (CAM).
Results Infants were randomised into the FP (n=107) or placebo (n=104) groups. No significant differences were detected between the FP and placebo groups with respect to either the frequency of death or the oxygen dependence at discharge or NDIs. In subgroup analyses, the frequencies of death and oxygen dependence at discharge were significantly decreased in the FP group for infants born at 24–26 GWs and for infants with CAM, regardless of the GW at birth.
Conclusions Inhaled steroids have no effect on the prevention of severe BPD or long-term NDI but might decrease the severity of BPD for ELBWIs with a risk factor.
Trial registration number UMIN-CTR C000000405.
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Collaborators The following individuals collected the data from infants for this trial: Hosono S (Nihon University Itabashi Hospital), Aoki M (National Nagasaki Medical Center), Makiya T (Okinawa Prefectural Chubu Hospital), Nishikubo T (Nara Medical University), Ichiba H (Osaka City General Hospital), Oki S (Seirei Hamamatsu Hospital), Futatani T (Toyama Prefectural Central Hospital), Tokuda S (Kyoto Prefectural University of Medicine), Minosaki Y (Kawaguchi Municipal Medical Center), Sobajima H (Saitama Medical Center, Saitama Medical University), Matsunami K (Osaka Medical Center and Research Institute for Maternal and Child Health) and Hiroma T (Nagano Children's Hospital).
Contributors TN conceptualised and designed the study, drafted the initial manuscript and approved the final manuscript as submitted. NY and FA designed the analysis plan, performed the data analysis and approved the final manuscript as submitted. MN examined the placentas of all enrolled infants and approved the final manuscript as submitted. SH and SK monitored the study data and approved the final manuscript as submitted. MF and MT critically reviewed and revised the manuscript and approved the final manuscript as submitted.
Funding This study was funded by a Health Labour Sciences Research Grant from the Japanese Ministry of Health, Labour and Welfare.
Competing interests None declared.
Patient consent Patient consent was obtained before each subject was enrolled.
Ethics approval The study protocol was approved by the institutional review boards of all participating institutions. This randomised, double-blinded, placebo-controlled trial was approved by the institutional ethics committee for human investigations.
Provenance and peer review Not commissioned; externally peer reviewed.
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