Clinicoetiological spectrum and outcomes of children with acute diarrhea and severe acute malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Primary outcome variable: Difference in mean duration of hospital stay between children with acute diarrhea and severe acute malnutrition and those with SAM and Hospitalization.
研究概览
简要总结
Stool samples (approx. 5g) will be collected in sterile containers and transported to the Enterobacteriaceae laboratory within two hours. If delayed beyond two hours, the sample will be partially inoculated in enrichment media (selenite F broth and alkaline peptone water) and stored at 4–8°C, to be delivered within 12 hours.
The stool samples will undergo:
- Macroscopic examination – for color, consistency, blood, mucus, or worms.
- Microscopic examination – using saline and iodine wet mounts to detect protozoa, helminths, and other components.
- Culture – on selective media after direct and enrichment inoculation; organisms will be identified via colony morphology, biochemical tests, and MALDI-TOF.
- Serotyping – confirmed with slide agglutination using specific antisera for Salmonella and Shigella.
- Antimicrobial susceptibility testing – performed using disk diffusion and broth microdilution methods as per CLSI guidelines.
The study will be carried out at Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, under standard protocols from the Ministry of Health and Family Welfare, India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Group 1 : Children aged 6 months to 5 years diagnosed with acute diarrhea (less than or equal to 14 days duration) with SAM ( as per WHO criteria).
- •Group 2: SAM children without diarrhea needing hospitalization .
排除标准
- •1.Chronic diarrhea .
- •2.Congenital or metabolic disorders affecting growth or gut function.
- •3.Re-admissions or referred cases after treatment elsewhere.
- •4.Coexisting chronic systemic illness (e.g. chronic heart, kidney, hematological, liver, or gastrointestinal disease), known primary/acquired immunodeficiency or immunosuppression.
结局指标
主要结局
Primary outcome variable: Difference in mean duration of hospital stay between children with acute diarrhea and severe acute malnutrition and those with SAM and Hospitalization.
时间窗: 1 week
次要结局
- 1.Median duration in clinical rehydration (in hours) and stool recovery (Bristol 5 or less) between the two groups.(2.Proportion of bacterial and parasitic pathogen in stool sample from Group 1.)
研究者
Manik Kotra
Maulana Azad Medical College and Lok Nayak Hospital