当前位置: X-MOL 学术N. Engl. J. Med. › 论文详情
Lower versus Traditional Treatment Threshold for Neonatal Hypoglycemia.
The New England Journal of Medicine ( IF 70.670 ) Pub Date : 2020-02-06 , DOI: 10.1056/nejmoa1905593
Anne A M W van Kempen,P Frank Eskes,Debbie H G M Nuytemans,Johanna H van der Lee,Lea M Dijksman,Nicole R van Veenendaal,Flip J P C M van der Hulst,Rob M J Moonen,Luc J I Zimmermann,Ellen P van 't Verlaat,Minouche van Dongen-van Baal,Ben A Semmekrot,Hélène G Stas,Ron H T van Beek,José J Vlietman,Peter H Dijk,Jacqueline U M Termote,Rogier C J de Jonge,Amerik C de Mol,Marianne W A Huysman,Joke H Kok,Martin Offringa,Nicole Boluyt,

BACKGROUND Worldwide, many newborns who are preterm, small or large for gestational age, or born to mothers with diabetes are screened for hypoglycemia, with a goal of preventing brain injury. However, there is no consensus on a treatment threshold that is safe but also avoids overtreatment. METHODS In a multicenter, randomized, noninferiority trial involving 689 otherwise healthy newborns born at 35 weeks of gestation or later and identified as being at risk for hypoglycemia, we compared two threshold values for treatment of asymptomatic moderate hypoglycemia. We sought to determine whether a management strategy that used a lower threshold (treatment administered at a glucose concentration of <36 mg per deciliter [2.0 mmol per liter]) would be noninferior to a traditional threshold (treatment at a glucose concentration of <47 mg per deciliter [2.6 mmol per liter]) with respect to psychomotor development at 18 months, assessed with the Bayley Scales of Infant and Toddler Development, third edition, Dutch version (Bayley-III-NL; scores range from 50 to 150 [mean {±SD}, 100±15]), with higher scores indicating more advanced development and 7.5 points (one half the SD) representing a clinically important difference). The lower threshold would be considered noninferior if scores were less than 7.5 points lower than scores in the traditional-threshold group. RESULTS Bayley-III-NL scores were assessed in 287 of the 348 children (82.5%) in the lower-threshold group and in 295 of the 341 children (86.5%) in the traditional-threshold group. Cognitive and motor outcome scores were similar in the two groups (mean scores [±SE], 102.9±0.7 [cognitive] and 104.6±0.7 [motor] in the lower-threshold group and 102.2±0.7 [cognitive] and 104.9±0.7 [motor] in the traditional-threshold group). The prespecified inferiority limit was not crossed. The mean glucose concentration was 57±0.4 mg per deciliter (3.2±0.02 mmol per liter) in the lower-threshold group and 61±0.5 mg per deciliter (3.4±0.03 mmol per liter) in the traditional-threshold group. Fewer and less severe hypoglycemic episodes occurred in the traditional-threshold group, but that group had more invasive diagnostic and treatment interventions. Serious adverse events in the lower-threshold group included convulsions (during normoglycemia) in one newborn and one death. CONCLUSIONS In otherwise healthy newborns with asymptomatic moderate hypoglycemia, a lower glucose treatment threshold (36 mg per deciliter) was noninferior to a traditional threshold (47 mg per deciliter) with regard to psychomotor development at 18 months. (Funded by the Netherlands Organization for Health Research and Development; HypoEXIT Current Controlled Trials number, ISRCTN79705768.).
更新日期:2020-02-06

 

全部期刊列表>>
向世界展示您的会议墙报和演示文稿
全球疫情及响应:BMC Medicine专题征稿
欢迎探索2019年最具下载量的化学论文
新版X-MOL期刊搜索和高级搜索功能介绍
化学材料学全球高引用
ACS材料视界
南方科技大学
x-mol收录
南方科技大学
自然科研论文编辑服务
西湖大学
中国科学院长春应化所于聪-4-8
武汉工程大学
课题组网站
X-MOL
深圳大学二维材料实验室张晗
中山大学化学工程与技术学院
试剂库存
天合科研
down
wechat
bug