Comparison of clinical profile, outcome and peripheral blood cell population data in children with COVID-19 and non-COVID acute severe respiratory infection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mode of oxygen therapy. Other interventions needed. Outcome from illnes- recovery or death
研究概览
简要总结
Background:
An outbreak of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 was first detected in Wuhan, Hubei, China. People of all ages are susceptible to SARS-CoV-2 infection. No information on severe pediatric patients with COVID-19 has been reported from India. We aimed to describe the clinical features and outcome of children admitted with acute lower respiratory infection (LARI) in Pediatric wards and to compare cell counter white blood cell data and indices of children with COVID infection with those with non-COVID acute respiratory illness (non-COVID ARI) including pneumonia and very severe disease.
Methods:
We will collect demographic information and clinical characteristics including exposure history, clinical signs and symptoms, chest computed tomographic (CT) scan or X-ray results, complications, treatments, clinical outcomes, and laboratory findings of children with COVID and non Covid ALRI. COVID-19 was confirmed in all patients by positive results of real-time reverse transcription-polymerase chain reaction (RT-PCR) assay for nasopharyngeal swab specimens. Data on patients with laboratory-confirmed 2019-nCoV infection will be obtained with standardized data collection forms. Researchers also directly communicated with patients or their families to ascertain epidemiological and symptom data. Data on laboratory tests including a complete blood count (leucocytes, neutrophils, lymphocytes, thrombocyte, hemoglobin), serum biochemistry (C-reactive protein, procalcitonin, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin, creatine kinase, creatinine and D-dimer) will be collected. We will also look for other system involvement in children with COVID-19. Outcomes like discharged home or death will be also collected.
Analysis: The basic demographic, clinical characteristics, laboratory parameters, and treatment outcome of this cohort at diagnosis will be analyzed. We intend to summarize subject characteristics by median and interquartile range (IQR) for continuous variables and frequency and percentage for categorical variables.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 16.00 Year(s)(—)
- 性别
- All
入选标准
- •All children from birth to 16 years of age presented with ALRI as per IMNCI criteria.
排除标准
- •Children with ALRI but having asthma, empyema, aspiration pneumonia.
结局指标
主要结局
Mode of oxygen therapy. Other interventions needed. Outcome from illnes- recovery or death
时间窗: Baseline, 3rd day, 5th day and at dischargefrom hospital.
次要结局
- Other systemic manifestations: Cardio vascular(Dermatological)
