Study of Two Doses of Pegylated Interferon Alpha-2b Nebulization to Treat Common Hand, Foot, and Mouth Disease in Children Aged 1 to 6 Years

What this Trial Is About

Researchers are evaluating the safety and effectiveness of inhaled Peginterferon alpha-2b at two different doses combined with supportive care for children aged 1 to 6 years who have common hand, foot, and mouth disease HFMD. This multicenter clinical trial aims to better understand treatment options for this illness by comparing two dose levels of the medicine delivered by nebulization. The study is sponsored by Zhengzhou Childrens Hospital in China and plans to enroll 90 participants. Participants will be randomly assigned to one of two groups receiving either 45 mcg or 90 mcg doses of nebulized Peginterferon alpha-2b on Day 1 and Day 3, alongside standard supportive care. The study includes a 3-day screening period followed by a 5-7 day inpatient treatment phase during which the investigational treatments are administered. The trial focuses on monitoring responses to these treatments while participants remain hospitalized. During participation, children will be closely monitored for the resolution of fever, skin rash, oral ulcers, and feeding difficulties over the first week. Researchers will collect data on the time it takes for these symptoms to improve or resolve. They will also assess safety by tracking any serious complications such as pulmonary edema or myocarditis. The total participation involves screening, inpatient observation, and follow-up to measure treatment outcomes and safety.

Clinical Trial of Pegylated Interferon α-2b Via Nebulization for Treatment of Hand, Foot, and Mouth Disease .