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

Phase 4

Recruiting

• Conditions: Infantile Hemangioma
• Interventions: Drug: Propranolol three times a day; Drug: Propranolol twice a day; Drug: Timolol

• Registration Number: NCT05479123
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-23
• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-07-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11
• Primary Completion: 2025-03-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• clinically diagnosed hemangiomas.
• English or Spanish speaking only

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ter in die (TID)three times a day	Propranolol three times a day	-
bis in die (BID)twice a day	Propranolol twice a day	-
Control	Timolol	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States