Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas
NCT ID: NCT05479123
Last Updated: 2023-12-11
Study Results
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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RECRUITING
PHASE4
174 participants
INTERVENTIONAL
2022-06-23
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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ter in die (TID)three times a day
Propranolol three times a day
Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen:
Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.
bis in die (BID)twice a day
Propranolol twice a day
Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen:
Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.
Control
Timolol
Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Interventions
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Propranolol three times a day
Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen:
Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.
Propranolol twice a day
Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen:
Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.
Timolol
Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Eligibility Criteria
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Inclusion Criteria
* English or Spanish speaking only
Exclusion Criteria
* Significant cardiac or pulmonary disease who are unable to tolerate oral propranolol
18 Months
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Matthew Greives
Associate Professor
Principal Investigators
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Matthew R Greives, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Matthew R Greives, MD
Role: primary
Chioma Obinero
Role: backup
Other Identifiers
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HSC-MS-22-0246
Identifier Type: -
Identifier Source: org_study_id