infantile hemangioma
Conditions
Interventions
Treatment with propranolol hydrochloride oral solution group:NA
Sponsors
Jinan Children's Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 1.Days of age is 35 days - 1 year (based on the year, month, and day of the Gregorian calendar, including boundary values, based on the date of the day of knowledge); male or female; 2.Infants weighing >=2kg; 3.The diagnosis of infantile hemangioma was confirmed according to the International Society for the Study of Vascular Anomalies (ISSVA) criteria for classification and nomenclature of vascular disorders (2018 edition), taking into account the history, clinical presentation, and ultrasonography of the hemangioma; 4.Children with infantile hemangiomas requiring systemic therapy; 5.The infant has not received any anti-hemangioma treatment within the last 30 days; 6.Guardian consent for the child to be treated with propranolol or to receive combination therapy; 7.Guardians were able to understand the purpose of the study, participated voluntarily and signed an informed consent form; 8.The guardian agrees to follow-up visits and follows the requirements of the treatment program.
Exclusion criteria
Exclusion criteria: 1.Special types of infantile hemangiomas in combination with other lesions, such as PHACE syndrome and LUMAR (SACRAL/ PELVIS) syndrome, craniofacial hemangiomatosis; 2.Fever within 1 week prior to first dose and/or current localized, systemic infection; 3.Breastfed infants whose mothers are receiving treatment requiring the prohibition of propranolol; 4.Infants or their mothers are hypersensitive to propranolol or any other ingredient of this product; 5.History of asthma or bronchospasm or current infectious diseases of the respiratory system; 6.Suffering from sinus node pathology (including sinus block), second or third degree AV block, decompensated heart failure, risk of coronary artery spasm, cardiogenic shock or severe bradycardia; 7.A history of severe hypotension; 8.A history of hypoglycemia; 9.Severe peripheral arterial circulatory disturbances (Raynaud's phenomenon); 10.Pheochromocytoma; 11.Diagnosed congenital hemangiomas, Kaposi's hemangioendothelioma and other tumors of vascular origin; 12.Any surgery within 4 weeks prior to screening or planned surgery during the trial; 13.History of medication use in infants and children prior to screening (only medications with therapeutic effects on hemangiomas); 14.Incomplete information; 15.Poor guardian compliance; 16.Any other condition that, in the opinion of the investigator, makes enrollment in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood flow signal richness on ultrasound; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events during treatment;cure rate; | — |
Countries
China
Contacts
Public ContactLei Guo
Jinan Children's Hospital
Outcome results
None listed