Abstract:

Objective To design an anti-splashing anal fecal specimen sampler for infants and young children，and evaluate its application effectiveness. Methods The sampler was made of medical-grade flexible plastic material，integrating a liquid-storage balloon for suction under negative pressure，a one-way valve on a ventilation tube to prevent splashing，and a pre-lubricated coating structure. It was sterilized with ethylene oxide and packaged in independent paper-plastic packaging. For clinical application，400 infants requiring fecal sampling at a tertiary Grade A hospital in Hangzhou from March to April 2025 were selected and randomly divided into an experimental group （using the novel sampler，n=200） and a control group（using traditional anal swabs，n=200）. The success rate of sample collection，intestinal mucosal injury rate，fecal splashing rate，pediatric comfort level，and nurse satisfaction were compared between the two groups. Results The success rate of sample collection in the experimental group was 100.0%，significantly higher than that in the control group（93.0%）（χ²=14.508，P<0.001）. The mucosal injury rate（0 vs 3.0%，P=0.013） and fecal splashing rate（0 vs 7.0%，P<0.001） in the experimental group were significantly lower than those in the control group. The proportion of moderate to severe discomfort in the experimental group（23.0%） was lower than that in the control group（41.0%），and nurse satisfaction in the experimental group（98.0%） was higher than that in the control group（86.0%），with all differences being statistically significant（P<0.001）. Conclusion This design significantly enhances the safety and operational efficiency of fecal sampling in infants and young children，achieving zero mucosal damage and zero splash contamination，thereby increasing the comfort of pediatric patients and the satisfaction of nurses.

Key words: Infant, Fecal Specimen Collection, Anti-Splashing, Suction Under Negative Pressure, Equipment Design