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

Infantile Hemangioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05479123
• Other study ID #: HSC-MS-22-0246
• Status: Recruiting
• Phase: Phase 4
• Start date: June 23, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Matthew R Greives, MD
• Phone: 713-500-7275
• Email: Matthew.R.Greives[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: July 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma, Capillary
• Infantile Hemangioma
• Port-Wine Stain

Intervention

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.
• 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.
• 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).

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of sleep awakenings per night as assessed by the Brief Infant Sleep Questionnaire(BISQ)		6 months from baseline
Secondary	Total amount of time subject is awake at night		3 months from baseline
Secondary	Total amount of time subject is awake at night		6 months from baseline
Secondary	Total amount of time subject is awake at night		9 months from baseline
Secondary	Total amount of time subject is awake at night		12 months from baseline
Secondary	Total amount of time subject is awake at night		15 months from baseline
Secondary	Total amount of time subject is awake at night		18 months from baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Amount of time it takes for subject to fall asleep		3 months from baseline
Secondary	Amount of time it takes for subject to fall asleep		6 months from baseline
Secondary	Amount of time it takes for subject to fall asleep		9 months from baseline
Secondary	Amount of time it takes for subject to fall asleep		12 months from baseline
Secondary	Amount of time it takes for subject to fall asleep		15 months from baseline
Secondary	Amount of time it takes for subject to fall asleep		18 months from baseline
Secondary	Longest stretch of time the subject is asleep without waking up		3 months from baseline
Secondary	Longest stretch of time the subject is asleep without waking up		6 months from baseline
Secondary	Longest stretch of time the subject is asleep without waking up		9 months from baseline
Secondary	Longest stretch of time the subject is asleep without waking up		12 months from baseline
Secondary	Longest stretch of time the subject is asleep without waking up		15 months from baseline
Secondary	Longest stretch of time the subject is asleep without waking up		18 months from baseline
Secondary	Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas		3 months from baseline
Secondary	Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas		6 months from baseline
Secondary	Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas		9 months from baseline
Secondary	Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas		12 months from baseline
Secondary	Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas		15 months from baseline
Secondary	Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas		18 months from baseline
Secondary	Number of participants with side effects		18 months from baseline