Systemic Propranolol for the Treatment of Paediatric Patients With Infantile Hemangiomas

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

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.

Study Overview

• Status: Completed
• Conditions: Infantile Haemangiomas
• Intervention / Treatment: Drug: propranolol; Device

• Study Type: Observational
• Enrollment (Actual): 128

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Overall, 52 males and 76 females, with a male-to-female ratio of 1:1.46, were included in this study. Of the 128 patients, 16 (12.5%) were born prematurely. The median age at the start of propranolol therapy was 3.75 months (0.5-12.5 months). Propranolol was administered for a median duration of 10.52 months (2-24 months).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Propranolol treatment group	Drug: propranolol; This retrospective study included 128 patients treated with oral propranolol at a dose of 2.0 mg/kg per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Shaohua Liu, Dr., Qilu Hospital of Shandong University

Publications and helpful links

General Publications

• 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.
• Hoeger PH, Harper JI, Baselga E, Bonnet D, Boon LM, Ciofi Degli Atti M, El Hachem M, Oranje AP, Rubin AT, Weibel L, Leaute-Labreze C. Treatment of infantile haemangiomas: recommendations of a European expert group. Eur J Pediatr. 2015 Jul;174(7):855-65. doi: 10.1007/s00431-015-2570-0. Epub 2015 May 29.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2010
• Primary Completion (Actual): December 15, 2017
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Congenital Abnormalities; Skin Abnormalities; Neoplasms, Vascular Tissue; Hemangioma, Capillary; Port-Wine Stain; Hemangioma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: LiuSH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes