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

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

Study Overview

• Status: Recruiting
• Conditions: Infantile Hemangioma
• Intervention / Treatment: Drug: Propranolol three times a day; Drug: Propranolol twice a day; Drug: Timolol

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Matthew R Greives, MD; Phone Number: 713-500-7275; Email: Matthew.R.Greives@uth.tmc.edu
• Study Contact Backup: Name: Chioma Obinero; Phone Number: 713-500-7216; Email: Chioma.G.Obinero@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Matthew R Greives, MD; Phone Number: 713-500-7275; Email: Matthew.R.Greives@uth.tmc.edu
      • Contact: Chioma Obinero; Phone Number: 713-500-7216; Email: Chioma.G.Obinero@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of sleep awakenings per night as assessed by the Brief Infant Sleep Questionnaire(BISQ)	6 months from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of time subject is awake at night		3 months from baseline
Total amount of time subject is awake at night		6 months from baseline
Total amount of time subject is awake at night		9 months from baseline
Total amount of time subject is awake at night		12 months from baseline
Total amount of time subject is awake at night		15 months from baseline
Total amount of time subject is awake at night		18 months from baseline
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)	will be assessed categorically from very easy, somewhat easy, neither easy nor difficulty, somewhat difficult or very difficult.	3 months from baseline
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)	will be assessed categorically from very easy, somewhat easy, neither easy nor difficulty, somewhat difficult or very difficult.	6 months from baseline
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)	will be assessed categorically from very easy, somewhat easy, neither easy nor difficulty, somewhat difficult or very difficult.	9 months from baseline
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)	will be assessed categorically from very easy, somewhat easy, neither easy nor difficulty, somewhat difficult or very difficult.	12 months from baseline
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)	will be assessed categorically from very easy, somewhat easy, neither easy nor difficulty, somewhat difficult or very difficult.	15 months from baseline
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)	will be assessed categorically from very easy, somewhat easy, neither easy nor difficulty, somewhat difficult or very difficult.	18 months from baseline
Amount of time it takes for subject to fall asleep		3 months from baseline
Amount of time it takes for subject to fall asleep		6 months from baseline
Amount of time it takes for subject to fall asleep		9 months from baseline
Amount of time it takes for subject to fall asleep		12 months from baseline
Amount of time it takes for subject to fall asleep		15 months from baseline
Amount of time it takes for subject to fall asleep		18 months from baseline
Longest stretch of time the subject is asleep without waking up		3 months from baseline
Longest stretch of time the subject is asleep without waking up		6 months from baseline
Longest stretch of time the subject is asleep without waking up		9 months from baseline
Longest stretch of time the subject is asleep without waking up		12 months from baseline
Longest stretch of time the subject is asleep without waking up		15 months from baseline
Longest stretch of time the subject is asleep without waking up		18 months from baseline
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas		3 months from baseline
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas		6 months from baseline
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas		9 months from baseline
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas		12 months from baseline
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas		15 months from baseline
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas		18 months from baseline
Number of participants with side effects		18 months from baseline

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Matthew R Greives, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Congenital Abnormalities; Skin Abnormalities; Neoplasms, Vascular Tissue; Hemangioma, Capillary; Port-Wine Stain; Hemangioma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol; Timolol
• Other Study ID Numbers: HSC-MS-22-0246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No