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

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

Conditions: Infantile Hemangioma

Treatments: Drug: Propranolol three times a day; Drug: Timolol; Drug: Propranolol twice a day

Study type: Interventional

Funder types: Other

Identifiers

NCT05479123

HSC-MS-22-0246

Details and patient eligibility

About

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

Enrollment: 174 estimated patients

Sex: All

Ages: Under 18 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinically diagnosed hemangiomas.
• English or Spanish speaking only

Exclusion criteria

• Parents who do not consent to the study.
• Significant cardiac or pulmonary disease who are unable to tolerate oral propranolol

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 3 patient groups

ter in die (TID)three times a day

Experimental group

Treatment:

Drug: Propranolol three times a day

bis in die (BID)twice a day

Experimental group

Treatment:

Drug: Propranolol twice a day

Control

Active Comparator group

Treatment:

Drug: Timolol