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临床试验/CTRI/2025/07/090821
CTRI/2025/07/090821尚未招募不适用

Efficacy of zinc as an adjuvant therapy in the treatment of severe pneumonia in hospitalised children between 2 months to 5 years of age:randomised controlled trial

Mudukanagouda1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2025年7月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
41
试验地点
1
主要终点
Improvement of tachypnea in hours at the time of discharge

研究概览

简要总结

After taking consent, patient demographic details, including name, age, sex, and address, will be delicately obtained from parents to uphold full privacy. The patient will undergo standard pneumonia treatment as per Karnataka institute of medical sciences, Hubli standard operation protocol (SOP). Blood sample collected for serum zinc level at the time of admission. Subsequently, children will be randomly assigned to Groups A and B by computer randomisation. Group A will receive syrup zinc (10 mg/day in children under 6 months of age and 20 mg/day in children above 6 months of age during hospitalisation for 7 days) along with antibiotics. In contrast, Group B will solely receive antibiotics without zinc supplementation. Respiratory rate, tachypnea definition based on age (respiratory rate >50 breaths/min in children <12 months of age, or >40 breaths/min in children >12 months of age), nasal flaring, and chest indrawing and oxygen saturation (SpO2) will be observed every 8 hourly, with SpO2 below 90% classified as hypoxemia. For patients on oxygen therapy, after 2-minute cessation we will assess respiratory rate, chest indrawing, and oxygen saturation. Clinical deterioration will be assessed by respiratory rate and signs of severe pneumonia. Continuous monitoring will occur and documentation done every 8th hourly extending until resolution of symptoms of pneumonia. All data will be meticulously recorded in a predefined proforma, strictly following exclusion criteria to control confounders and bias in study results.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
2.00 Month(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • As per WHO guidelines: Child with severe pneumonia with clinical features of lower chest indrawing, Unable breastfeed, lethargy, convulsions, unconsciousness, severe respiratory distress, central cyanosis.

排除标准

  • Children with any congenital heart disease, congenital lung disease, Children with aspiration pneumonia, Children with history of wheezing and recurrent chest infection, Children already taking zinc 2 weeks prior to study Children who need mechanical ventilation are excluded from this study.

结局指标

主要结局

Improvement of tachypnea in hours at the time of discharge

时间窗: Improvement of tachypnea in hours at the time of discharge

次要结局

  • Improvement in chest indrawing in hours,Improvement in oxygen saturation in hours,Baseline serum zinc level Duration of Hospitalisation (h)(Improvement in chest indrawing in hours,Improvement in oxygen saturation in hours,Baseline serum zinc level Duration of Hospitalisation (h))

研究者

发起方
Mudukanagouda
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

MUDUKANAGOUDA

Karnataka medical college and research institute

研究点 (1)

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