NCT05479123

Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the baseline sleep pattern disruption for patients starting oral propranolol at the standard BID dosing regimen compared to the control (timolol) group and to determine if there is a significant improvement in the sleep patterns in infants taking oral propranolol on the TID dosing regimen versus the control (timolol) group

Conditions

• Infantile Hemangioma

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
DRUG	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).

Timeline

• Start date: 2022-06-23
• Primary completion: 2025-03-31
• Completion: 2025-07-31
• First posted: 2022-07-29
• Last updated: 2026-03-13
• Results posted: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study