跳至主要内容
临床试验/NCT03133637
NCT03133637已完成不适用

Effect of Ceftriaxone on Neonatal Jaundice

University of Rochester1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
change in bilirubin binding assays

研究概览

简要总结

Ceftriaxone is an antibiotic often used for the management of sepsis. Neonates commonly have jaundice during the first postnatal week. Ceftriaxone will be given as standard of care for sepsis and investigators will observe the effect on jaundice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Days 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Term infants with sepsis requiring IV antibiotics for more than 3 days and who has total serum bilirubin 6-12 mg/dL and resolving by day 4 of life.

排除标准

  • Infants with asphyxia (Apgar score <3 at 5 minutes), chromosomal disorder, failed hearing test at baseline, family history of hearing loss, unconjugated hyperbilirubinemia requiring phototherapy, TORCH infection, craniofacial malformations, listeria monocytogenes infection, and any clinical conditions which will preclude discharge to home.

研究组 & 干预措施

Ceftriaxone Arm

干预措施: ceftriaxone (Drug)

结局指标

主要结局

change in bilirubin binding assays

时间窗: baseline and through study completion, an average of 1 hour

次要结局

  • Automated brain stem evoke response test(through study completion, an average of 1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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