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临床试验/NCT00252304
NCT00252304已完成2 期

Efficacy of Zinc as Adjuvant Therapy in the Treatment of Severe Pneumonia in Nepalese Children at the Kanti Children's Hospital

Centre For International Health1 个研究点 分布在 1 个国家目标入组 641 人开始时间: 2006年1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
641
试验地点
1
主要终点
Time to cessation of severe pneumonia

研究概览

简要总结

The aim of this study is to assess whether zinc given as adjuvant therapy to standard antibiotic treatment in children hospitalized for severe pneumonia reduces the duration of the severe illness and risk of treatment failure. A randomized double blind placebo controlled clinical trial will be conducted at the Kanti Hospital.

详细描述

Nepal has an under-five mortality rate of 91/1000 live births. Pneumonia, one of the major killers accounts for the death of 25,000 - 35,000 Nepalese children every year. It is estimated that, on an average, of 1000 children <5 years of age that visit health facilities, 90 have pneumonia of which 4.2 have severe pneumonia. At the Kanti Children's Hospital, respiratory diseases are the most frequent reason for admission and the second most frequent cause of child death Zinc, an important micronutrient, is crucial for the normal function of the immune system as well as the integrity of the respiratory epithelium. Zinc deficiency is associated with an increased incidence and severity of diarrhea and respiratory tract infections. The preventive effect of zinc on diarrheal and respiratory illness has been well documented.

Early in an infection zinc is shifted into the liver from the plasma, bone, skin and intestines. For a child with initial low zinc levels, even relatively trivial infections may cause entry into the vicious cycle of reduced plasma zinc and increased infection severity. Administration of zinc during the acute illness may help in reducing the severity of illness.

The therapeutic effect of zinc in acute diarrhea has been well documented. In a study conducted at Bhaktapur, Nepal, in children 6 to 36 months of age, supplementation with zinc was found to be highly effective in the treatment of acute diarrhea.

The Kanti Children's Hospital in Kathmandu serves as a general and referral hospital for children from all parts of the country. Approximately 25% of all admissions to this hospital are due to pneumonia. Being the only well recognized children's hospital, there is always a constraint for available beds for children presenting with pneumonia. Zinc as an adjuvant to standard treatment of pneumonia with antimicrobials was found to hasten recovery from severe pneumonia in children less than 2 years of age in Bangladesh . If we were to conduct a similar study and prove that zinc does in fact help to shorten the duration of illness in children with severe pneumonia, it would go a long way in contributing to improve case management.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
2 Months 至 35 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 2- 35 months with a history of cough (duration <14days) and difficult breathing of </= 72hours' duration, with lower chest indrawing.
  • Availability of informed consent.

排除标准

  • Children with severe wasting (<70% NCHS median weight for height)
  • Severe anemia (hemoglobin <7 gm/dl.)
  • Presence of heart disease with or without signs of cardiac failure.
  • Child with a chronic cough (lasting for ≥14 days)
  • Documented tuberculosis with ongoing treatment.
  • Associated other severe diseases that require special care or surgical intervention.
  • Children with concomitant diarrhea with some/severe dehydration
  • Children with a history of recurrent wheezing
  • Children enrolled in the study within the last 6 months of this visit

研究组 & 干预措施

Zinc

Experimental

Zinc sulphate 10 or 20 mg per day

干预措施: Zinc (zinc sulphate) (Drug)

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Time to cessation of severe pneumonia

时间窗: Within 2 weeks after enrollment

The period starting from enrolment to the beginning of a 24-hour consecutive period of absence of lower chest indrawing, of hypoxia and of any danger signs.

时间窗: Recovery from pneumonia within 2 weeks

次要结局

未报告次要终点

研究者

发起方
Centre For International Health
申办方类型
Other

研究点 (1)

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