Systemic Propranolol for the Treatment of Paediatric Patients With Infantile Hemangiomas

Infantile Haemangiomas Clinical Trial

Official title:

Influence of Systemic Propranolol Treatment on the Physical Development of Paediatric Patients With Infantile Hemangiomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651049
• Other study ID #: LiuSH
• Status: Completed
• Start date: July 15, 2010
• Est. completion date: February 10, 2020

Study information

• Verified date: August 2020
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is retrospective study. The patients treated with oral propranolol at a dose of 2.0 mg/kg per day. Growth parameters (height and weight) were measured at the beginning, the end of treatment and 2 years after treatment. The weight-for-age Z-score (WAZ), height-for-age Z-score (HAZ) and weight-for-height Z-score (WHZ) calculated by the WHO Anthro software were used to assess physical development, and the WHO Child Growth Standards were used as the standards.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: February 10, 2020
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 54 Weeks

Eligibility

Inclusion Criteria:

• IHs diagnosed by medical history and physical examination
• no previous treatment with other medications

Exclusion Criteria:

• a history or risk of asthma, reactive airway disease, impaired renal or liver function, heart defects or arrhythmia, hypotension and hypersensitivity to propranolol
• Infants who did not adhere to the treatments or attend follow-up visits
• Infants with other known risk factors for developmental delay or growth restriction, such as prematurity, small for gestational age, or other major congenital malformations, were also excluded
• No other treatment was used during the oral propranolol course

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma, Capillary
• Infantile Haemangiomas
• Port-Wine Stain

Intervention

Drug:
• propranolol
This retrospective study included 128 patients treated with oral propranolol at a dose of 2.0 mg/kg per day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

References & Publications (2)

Chen ZY, Wang QN, Zhu YH, Zhou LY, Xu T, He ZY, Yang Y. Progress in the treatment of infantile hemangioma. Ann Transl Med. 2019 Nov;7(22):692. doi: 10.21037/atm.2019.10.47. Review. — View Citation

Hoeger PH, Harper JI, Baselga E, Bonnet D, Boon LM, Ciofi Degli Atti M, El Hachem M, Oranje AP, Rubin AT, Weibel L, Léauté-Labrèze C. Treatment of infantile haemangiomas: recommendations of a European expert group. Eur J Pediatr. 2015 Jul;174(7):855-65. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on the height of the patients	we recorded the height of the patients in meters.	at the beginning of the treatment, at the end of treatment and 2 years after the treatment
Primary	Change on the weight of the patients	we recorded the weight of the patients in kilograms.	at the beginning of the treatment, at the end of treatment and 2 years after the treatment