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临床试验/JPRN-UMIN000017591
JPRN-UMIN000017591已完成未知

Evaluation of depth and thickness in skin, subcutaneous and muscle tissue at vaccination sites in Japanese infants - Evaluation of depth and thickness in skin, subcutaneous and muscle tissue at vaccination sites in Japanese infants

Japan Vaccine Co.,Ltd0 个研究点目标入组 180 人开始时间: 2015年5月16日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
180

研究概览

简要总结

The thickness of the epidermis was 1.44 - 1.54 mm (95% CI), and the lengths from the skin surface to the muscle fascia and bone were 11.52 - 12.28 mm (95% CI), and 25.66 - 26.93 mm (95% CI), respectively, at the anterolateral thigh. At the center of the deltoid muscle, skin thickness was similar to that at the thigh, furthermore the lengths from the skin surface to the muscle fascia and bone were 8.49 - 9.10 mm (95% CI), and 17.38 - 18.31 mm (95% CI), respectively. The lengths from the skin surface to the muscle fascia and bone were 1 - 2 mm shorter in 2-month-old infants than those in older generations. Therefore, the appropriate needle length for intramuscular injections in Japanese infants was 16 mm (5/8 inch) at any age and sites, and with 25 mm (1 inch) needles at a 90-degree angle being associated with the risk of over-penetration.

研究设计

研究类型
Interventional

入排标准

年龄范围
2months-old 至 15months-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • (1) infant who has an abnormality in the measurement target site. (2) infant with who investigator judges stable and circumference measurements and image inspection is difficult. (3) infant who is suffering from severe acute and chronic disease. (4) infant who has an experience of any damage in the arms or legs. (5) infant who has or experienced all of neurological or muscle disease. (6) Other, infant who investigator judges ineligible as a subject. (7) infant whose written consent form is not obtained by his/her representative's own free will.

研究者

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