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Beta Blocker

Propranolol Dosing Frequency for Infantile Hemangiomas

Phase 4
Recruiting
Led By Matthew R Greives, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically diagnosed hemangiomas
English or Spanish speaking only
Must not have
Significant cardiac or pulmonary disease who are unable to tolerate oral propranolol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months from baseline
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is testing if a higher dose of propranolol, given three times a day instead of the standard two, can improve sleep patterns in infants with heart conditions.

Who is the study for?
This trial is for infants with diagnosed hemangiomas. Participants must have parents who consent to the study and can communicate in English or Spanish. Infants with significant heart or lung diseases that make it unsafe to take oral propranolol are not eligible.
What is being tested?
The study is testing how different dosing schedules of Propranolol (three times a day vs twice a day) affect sleep patterns in infants with hemangiomas, compared to a control group using Timolol.
What are the potential side effects?
Propranolol may cause sleep disturbances, slow heartbeat, low blood pressure, breathing difficulties, and cold hands and feet. Side effects vary by individual and dosage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a hemangioma.
Select...
I speak English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot take oral propranolol due to severe heart or lung disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: ter in die (TID)three times a dayExperimental Treatment1 Intervention
Group II: bis in die (BID)twice a dayExperimental Treatment1 Intervention
Group III: ControlActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
946 Previous Clinical Trials
344,115 Total Patients Enrolled
Matthew R Greives, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Propranolol (Beta Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05479123 — Phase 4
Infantile Hemangiomas Research Study Groups: bis in die (BID)twice a day, ter in die (TID)three times a day, Control
Infantile Hemangiomas Clinical Trial 2023: Propranolol Highlights & Side Effects. Trial Name: NCT05479123 — Phase 4
Propranolol (Beta Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05479123 — Phase 4
~21 spots leftby Mar 2025
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