Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy
Infantile Hemangioma
About this trial
This is an interventional treatment trial for Infantile Hemangioma focused on measuring Infantile Hemangioma, Propranolol
Eligibility Criteria
Inclusion Criteria:
- Proliferating IH (target hemangioma) requiring systemic therapy anywhere on the body except on the diaper area with largest diameter of at least 1.5 cm
Exclusion Criteria:
- The patient presents with one or more of the following medical conditions: Congenital hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycaemia (< 40 mg/dl or at risk); untreated phaeochromocytoma; hypotension (< 50/30 mmHg); second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia (< 80 bpm); severe peripheral arterial circulatory disturbances; Raynaud's phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal's angina; documented PHACES syndrome with central nervous system involvement
- The patient has previously been treated for IH, including any surgical and/or medical procedures (e.g. laser therapy)
- The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers
One or more of the following types of IH are present:
- Life-threatening IH
- Function-threatening IH (e.g. those causing impairment of vision, respiratory compromise caused by airway lesions, etc.)
- Ulcerated IH (whatever the localisation) with pain and lack of response to simple wound care measures
- The patient was born prematurely and has not yet reached his/her term equivalent age (e.g. an infant born 2 months prematurely cannot be included before the age of 2 months)
- LVEF (left ventricular systolic function) ≤40% and/or cardiomyopathy and/or hereditary arrhythmia disorder
Sites / Locations
- University of California
- Lucile Packard Children's Hospital
- Rady Children's Hospital
- Miami Children's Hospital
- Children's Memorial Hospital
- Cardinal Glennon Children's Hospital
- State University of NY
- Oregon Health Sciences University
- Dell Children's Medical center
- Seattle Children's Hospital
- Eastern Clinical Research Unit - Box Hill Hospital
- Royal Children's Hospital
- Sydney Children's Hospital
- CHU St.Justine
- The Hospital for Sick Children
- Children Dermatology
- Clinic of Dermatovenerology, University
- Hôpital Pellegrin-Enfants
- Hôpital Femme Mère Enfant
- CHU Hôtel Dieu
- Hôpital Archet 2
- Hôpital Armand Trousseau
- Hôpital Necker Enfants malades
- Hopital Robert Debre - Consultation de Dermatologie
- Hopital Nord-CHU St Etienne
- Hôpital des enfants
- Hôpital Clocheville
- Universitätsklinikum Freiburg
- Kinderkrankenhaus Wilhelmstift
- Universitätsklinikum Schleswig-Holstein
- Kinderchirurgische Klinik Ludwig-Maximilians-Universität
- Heim Pál Gyermekkórház,
- University of Bari
- Clinica Dermatologica
- Vilnius University Children's Hospital
- Hospital Infantil de Mexico Federico Gomez
- Auckland Dermatology
- Waikato Clinical Research 2008 Ltd.
- Clinica Internacional
- Hospital Nacional Edgardo Rebagliati Martins
- Instituto Nacional de Salud del Niño
- Klinika Chirurgii i Urologii Dzieci i Mlodziezy Akademii Medycznej
- University Children's Hospital
- Department of Pediatric Surgery and Oncology
- Klinika Onkologii, Centrum Zdrowia Dziecka
- Spitalul Clinic Urgenta pentru Copii Grigore Alexandrescu
- I.O.M.C Alfred Rusescu
- Spitalul de Copii Dr. Victor Gomoiu
- Spitalul Clinic de Urgenta pentu Copii Sf. Maria
- Spitalul de Urgenta Copii, Louis Turcanu
- Medical University - Filatov Pediatric Hospital
- Medical Pediatric Academy
- Neonatal Intensive Care Department
- Servicio de Dermatologia del Hospital Infantil
- Hospital Sant Pau de Barcelona
- Hospital Universitario Infantil Niño Jesús
- Hospital La Paz
- Hospital Universitario Virgen del Rocio
- Hospital Universitario de Valencia
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Propranolol oral solution
Placebo