Nakamura Tomohiko, Yonemoto Naohiro, Nakayama Masahiro, Hirano Shinya, Aotani Hirofumi, Kusuda Satoshi, Fujimura Masanori, Tamura Masanori
Division of Neonatology, Nagano Children's Hospital, Nagano, Japan.
Division of Neonatology, Department of Pediatrics, Shinshu University School of Medicine, Nagano, Japan.
Arch Dis Child Fetal Neonatal Ed. 2016 Nov;101(6):F552-F556. doi: 10.1136/archdischild-2015-309943. Epub 2016 Apr 8.
We hypothesised that a prophylactic inhaled steroid would prevent the progression of bronchopulmonary dysplasia (BPD) in extremely low birthweight infants (ELBWIs).
This study was a multicentre, randomised, double-blinded, placebo-controlled trial.
This investigation was conducted in 12 level III neonatal intensive care units (NICUs).
A total of 211 ELBWIs requiring ventilator support were enrolled.
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.
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).
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.
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.
UMIN-CTR C000000405.
我们假设预防性吸入类固醇可预防极低出生体重儿（ELBWIs）支气管肺发育不良（BPD）的进展。
本研究为多中心、随机、双盲、安慰剂对照试验。
本研究在12家三级新生儿重症监护病房（NICUs）进行。
共纳入211例需要呼吸机支持的ELBWIs。
出生后24小时内开始，持续至6周龄或拔管，每24小时给予两剂50μg丙酸氟替卡松（FP）或安慰剂。
用于指示严重BPD发病率的主要观察指标是NICU出院时的死亡或氧依赖情况。次要指标是月经后年龄18个月和3岁时的神经发育障碍（NDIs）。我们根据孕周（GW）和绒毛膜羊膜炎（CAM）的存在情况进行亚组分析。
婴儿被随机分为FP组（n = 107）或安慰剂组（n = 104）。在FP组和安慰剂组之间，出院时的死亡频率、氧依赖情况或NDIs方面均未检测到显著差异。在亚组分析中，对于出生时孕周为24 - 26周的婴儿以及患有CAM的婴儿，无论出生时的孕周如何，FP组出院时的死亡和氧依赖频率均显著降低。
吸入类固醇对预防严重BPD或长期NDIs无效，但可能降低有危险因素的ELBWIs的BPD严重程度。
UMIN - CTR C000000405。
