Efficacy of Zinc as Adjuvant Therapy in the Treatment of Severe Pneumonia in Nepalese Children at the Kanti Children's Hospital
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
- 否
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
Zinc sulphate 10 or 20 mg per day
干预措施: Zinc (zinc sulphate) (Drug)
Placebo
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
