Tomohiko Nakamura1,2, Naohiro Yonemoto3, Masahiro Nakayama4, Shinya Hirano5, Hirofumi Aotani6, Satoshi Kusuda7, Masanori Fujimura5, Masanori Tamura8. 1. Division of Neonatology, Nagano Children's Hospital, Nagano, Japan. 2. Division of Neonatology, Department of Pediatrics, Shinshu University School of Medicine, Nagano, Japan. 3. Department of Neuropsychopharmacology, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan. 4. Department of Clinical Laboratory Medicine and Anatomic Pathology, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan. 5. Department of Neonatal Medicine, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan. 6. Department of Pediatrics, Kyoto Kizukawa Hospital, Kyoto, Japan. 7. Department of Neonatal Medicine, Maternal and Perinatal Center, Tokyo Women's Medical Center, Tokyo, Japan. 8. Department of Pediatrics, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Abstract
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
RCT Entities:
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Authors: Kamini Raghuram; Michael Dunn; Krista Jangaard; Maureen Reilly; Elizabeth Asztalos; Edmond Kelly; Michael Vincer; Vibhuti Shah Journal: BMC Pediatr Date: 2018-05-07 Impact factor: 2.125