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Completed

NCT Number: NCT04651049

Systemic Propranolol for the Treatment 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.

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Key information

Age range

2 week–54 week

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propranolol

Drug

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

Primary outcomes

  1. Change on the height of the patients

    Time frame: at the beginning of the treatment, at the end of treatment and 2 years after the treatment

    we recorded the height of the patients in meters.

  2. Change on the weight of the patients

    Time frame: at the beginning of the treatment, at the end of treatment and 2 years after the treatment

    we recorded the weight of the patients in kilograms.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2017
Study completion
2020
First posted
Dec 3, 2020
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.