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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon α-2b 90 mcg dose group | Experimental | The experimental group participants inhaled Peginterferon on the basis of receiving symptomatic supportive treatment. |
|
| Recombinant human interferon α-2b dose group | Active Comparator | The control group participants received symptomatic supportive treatment and aerosolized inhalation therapy with recombinant human interferon α-2b. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon α-2b injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of change in Wang's bronchiolitis score from baseline. | Day 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Wang's bronchiolitis score change from baseline. | Day1-7. | |
| The proportion of Wang's bronchiolitis score being 0 points. | Day6. | |
| Length of hospital stay. |
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Inclusion Criteria:
Exclusion Criteria:
(10) Other conditions deemed unsuitable for inclusion by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuangli Hao, Ph.D | Contact | 13771905555 | hcl_md@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chuangli Hao, Ph.D | Children's Hospital of Soochow University | Principal Investigator |
| Fanzheng Meng, Ph.D | The First Hospital of Jilin University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Women and Children's Health Care Center | Not yet recruiting | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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|
| Recombinant Human Interferon α2b | Drug | 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. |
|
| through study completion, an average of 18 months |
| Duration of oxygen therapy support. | through study completion, an average of 18 months |
| Change in viral load from baseline. | through study completion, an average of 18 months |
| Adverse Event(AE). | through study completion, an average of 18 months |
| Body temperature. | through study completion, an average of 18 months |
| Number of Participants with Abnormal Laboratory Parameters Findings. | through study completion, an average of 18 months |
| The number of research subjects who withdrew early. | through study completion, an average of 18 months |
| Xiaoxia Lu, Ph.D |
| Wuhan women and children's health care center |
| Study Director |
| Children's Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | China |
|
| The First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | China |
|
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |