PMID- 27059072 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220310 IS - 1468-2052 (Electronic) IS - 1359-2998 (Linking) VI - 101 IP - 6 DP - 2016 Nov TI - Early inhaled steroid use in extremely low birthweight infants: a randomised controlled trial. PG - F552-F556 LID - 10.1136/archdischild-2015-309943 [doi] AB - 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 mug 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. CI - 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/. FAU - Nakamura, Tomohiko AU - Nakamura T AD - Division of Neonatology, Nagano Children's Hospital, Nagano, Japan. AD - Division of Neonatology, Department of Pediatrics, Shinshu University School of Medicine, Nagano, Japan. FAU - Yonemoto, Naohiro AU - Yonemoto N AD - Department of Neuropsychopharmacology, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan. FAU - Nakayama, Masahiro AU - Nakayama M AD - Department of Clinical Laboratory Medicine and Anatomic Pathology, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan. FAU - Hirano, Shinya AU - Hirano S AD - Department of Neonatal Medicine, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan. FAU - Aotani, Hirofumi AU - Aotani H AD - Department of Pediatrics, Kyoto Kizukawa Hospital, Kyoto, Japan. FAU - Kusuda, Satoshi AU - Kusuda S AD - Department of Neonatal Medicine, Maternal and Perinatal Center, Tokyo Women's Medical Center, Tokyo, Japan. FAU - Fujimura, Masanori AU - Fujimura M AD - Department of Neonatal Medicine, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan. FAU - Tamura, Masanori AU - Tamura M AD - Department of Pediatrics, Saitama Medical Center, Saitama Medical University, Saitama, Japan. CN - and The Neonatal Research Network, Japan LA - eng PT - Journal Article DEP - 20160408 PL - England TA - Arch Dis Child Fetal Neonatal Ed JT - Archives of disease in childhood. Fetal and neonatal edition JID - 9501297 OTO - NOTNLM OT - Neonatology OT - Respiratory COIS- Competing interests: None declared. FIR - Hosono, S IR - Hosono S FIR - Aoki, M IR - Aoki M FIR - Makiya, T IR - Makiya T FIR - Nishikubo, T IR - Nishikubo T FIR - Ichiba, H IR - Ichiba H FIR - Oki, S IR - Oki S FIR - Futatani, T IR - Futatani T FIR - Tokuda, S IR - Tokuda S FIR - Minosaki, Y IR - Minosaki Y FIR - Sobajima, H IR - Sobajima H FIR - Matsunami, K IR - Matsunami K FIR - Hiroma, T IR - Hiroma T EDAT- 2016/04/10 06:00 MHDA- 2016/04/10 06:01 CRDT- 2016/04/10 06:00 PHST- 2015/10/14 00:00 [received] PHST- 2016/03/16 00:00 [revised] PHST- 2016/03/18 00:00 [accepted] PHST- 2016/04/10 06:00 [pubmed] PHST- 2016/04/10 06:01 [medline] PHST- 2016/04/10 06:00 [entrez] AID - archdischild-2015-309943 [pii] AID - 10.1136/archdischild-2015-309943 [doi] PST - ppublish SO - Arch Dis Child Fetal Neonatal Ed. 2016 Nov;101(6):F552-F556. doi: 10.1136/archdischild-2015-309943. Epub 2016 Apr 8.