This is a multicenter, randomized, positive-controlled, non-inferiority clinical study, planning to enroll 90 children with bronchiolitis caused by respiratory syncytial virus infection, to evaluate the safety and efficacy of inhaled Peginterferon α-2b injection compared to recombinant human interferon α2b in the treatment of pediatric respiratory syncytial virus bronchiolitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
Peginterferon α-2b injection, 90 mcg, on the basis of conventional treatments such as asthma control, oxygen inhalation, and fluid replacement, nebulized inhalation using air compression or oxygen-driven methods is administered on days 1, 3, and 5, once a day.
Recombinant Human Interferon alpha 2b, at a dose of 100,000 IU/kg, based on the conventional treatments such as asthma control, oxygen inhalation, and fluid replacement, will be administered via nebulized inhalation using air compression or oxygen-driven methods from day 1 to day 5, twice daily.
Wuhan Women and Children's Health Care Center
Wuhan, Hubei, China
NOT_YET_RECRUITINGChildren's Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGThe First Hospital of Jilin University
Changchun, Jilin, China
NOT_YET_RECRUITINGThe rate of change in Wang's bronchiolitis score from baseline.
Time frame: Day 6.
Wang's bronchiolitis score change from baseline.
Time frame: Day1-7.
The proportion of Wang's bronchiolitis score being 0 points.
Time frame: Day6.
Length of hospital stay.
Time frame: through study completion, an average of 18 months
Duration of oxygen therapy support.
Time frame: through study completion, an average of 18 months
Change in viral load from baseline.
Time frame: through study completion, an average of 18 months
Adverse Event(AE).
Time frame: through study completion, an average of 18 months
Body temperature.
Time frame: through study completion, an average of 18 months
Number of Participants with Abnormal Laboratory Parameters Findings.
Time frame: through study completion, an average of 18 months
The number of research subjects who withdrew early.
Time frame: through study completion, an average of 18 months
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