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临床试验/NCT01567215
NCT01567215已完成2 期

Treatment of Granuloma Umbilical in Newborn Babies - Comparison of Treatment With Silver Nitrate Versus Alcohol Swaps Versus Steroid Creme Group IV

Pernille Pedersen2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Is alcohol swabs and steroid creme as effective as lapis in treatment of granuloma umbilica?

研究概览

简要总结

The investigators want to show that steroid creme and even better alcohol swaps are just as effective or equal to the current treatment with silver nitrate of granuloma umbilical in newborns.

详细描述

The change of treatment will make it possible for parents to treat the children themselves at home, whereas treatment with silver nitrate only is an in hospital regimen.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Weeks 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age more than 37 weeks
  • More than 3 weeks old baby
  • Granuloma umbilical diagnosed by a pediatrician
  • No infections due to the umbilicus
  • Parents do understand and speak danish

排除标准

  • Gestational age less than 37 weeks
  • Less than 3 weeks old baby
  • Granuloma umbilical not diagnosed by a pediatrician
  • Infections due to the umbilicus
  • Parents do not understand or speak Danish

研究组 & 干预措施

Granuloma

Experimental

干预措施: silver nitrate (Procedure)

Granuloma

Experimental

干预措施: Steroids (Drug)

Granuloma

Experimental

干预措施: alcohol (Procedure)

结局指标

主要结局

Is alcohol swabs and steroid creme as effective as lapis in treatment of granuloma umbilica?

时间窗: 2 years

Change current treatment of Grauloma Umbilical. Show that alcohol swaps or steroid creme group IV are just as effective as current treatment of granuloma umbilica with silver nitrate.

次要结局

  • Change of treatment of granuloma umbilical in hospitals by professionals to treatment at home by parents(2 years)

研究者

发起方
Pernille Pedersen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pernille Pedersen

Doctor Pernille Pedersen

Hvidovre University Hospital

研究点 (2)

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