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Systemic Propranolol for the Treatment of Paediatric Patients With Infantile Hemangiomas

NCT ID: NCT04651049

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-15

Study Completion Date

2020-02-10

Brief Summary

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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.

Detailed Description

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Conditions

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Infantile Haemangiomas

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Propranolol treatment group

propranolol

Intervention Type DRUG

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

Intervention Type DEVICE

Interventions

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propranolol

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

Intervention Type DRUG

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

2 Weeks

Maximum Eligible Age

54 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shaohua Liu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

References

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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.

Reference Type BACKGROUND
PMID: 31930093 (View on PubMed)

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.

Reference Type RESULT
PMID: 26021855 (View on PubMed)

Other Identifiers

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LiuSH

Identifier Type: -

Identifier Source: org_study_id