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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months from baseline

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I speak English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months from baseline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of sleep awakenings per night as assessed by the Brief Infant Sleep Questionnaire(BISQ)

Secondary outcome measures

Amount of time it takes for subject to fall asleep

Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas

Longest stretch of time the subject is asleep without waking up

+3 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,786 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots still available for prospective participants in this trial?

"Affirmative. Online data on clinicaltrials.gov indicates that this medical experiment, with its inception date being June 23rd 2022, is still accepting participants. The trial necessitates the recruitment of 174 patients from one site alone."

Answered by AI

What risks are associated with thrice daily doses of Propranolol?

"Due to the treatment being approved and in its fourth phase of trial, Propranolol taken three times a day is assessed as having an elevated safety rating of 3."

Answered by AI

How many participants can take part in this experimental research?

"Affirmative. The information posted on clinicaltrials.gov shows that this research trial is presently seeking to recruit 174 individuals at a single site. This study was first uploaded on June 23rd, 2022 and last edited on July 28th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Matthew Greives 2022. "Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05479123.