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

Purpose

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

Condition

  • Infantile Hemangioma

Eligibility

Eligible Ages
Under 18 Months
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ter in die (TID)three times a day
  • 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.
Experimental
bis in die (BID)twice a day
  • 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.
Active Comparator
Control
  • 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).

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Matthew R Greives, MD
713-500-7275
Matthew.R.Greives@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Matthew R Greives, MD
713-500-7275
Matthew.R.Greives@uth.tmc.edu