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

NCT05479123 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-22-0246
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of Sleep Awakenings Per Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)

  This item assesses the number of times the child wakes during the night, as reported by the caregiver response to the question, "How many times does your child usually wake during the night?" from a single item of the Brief Infant Sleep Questionnaire (BISQ).

  6 months from baseline

Secondary Outcomes (26)

• Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)

  3 months from baseline

• Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)

  6 months from baseline

• Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)

  9 months from baseline

• Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)

  12 months from baseline

• Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)

  15 months from baseline

Study Arms (3)

ter in die (TID)three times a day

EXPERIMENTAL

Drug: Propranolol three times a day

bis in die (BID)twice a day

EXPERIMENTAL

Drug: Propranolol twice a day

Control

ACTIVE COMPARATOR

Drug: Timolol

Interventions

Propranolol three times a day DRUG

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.

ter in die (TID)three times a day

Propranolol twice a day DRUG

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.

bis in die (BID)twice a day

Timolol DRUG

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).

Control

Eligibility Criteria

• Age: Up to 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• clinically diagnosed hemangiomas.
• English or Spanish speaking only

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hemangioma, Capillary

Interventions

Timolol

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Results Point of Contact

• Title: Matthew R Greives, MD
• Organization: The University of Texas Health Science Center at Houston

Matthew.R.Greives@uth.tmc.edu

713-500-7275

Study Officials

• Matthew R Greives, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: June 23, 2022
• Primary Completion: March 31, 2025
• Study Completion: July 31, 2025
• Last Updated: March 13, 2026
• Results First Posted: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)