Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas
Primary Purpose
Infantile Hemangioma
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Propranolol three times a day
Propranolol twice a day
Timolol
Sponsored by
About this trial
This is an interventional supportive care trial for Infantile Hemangioma
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
ter in die (TID)three times a day
bis in die (BID)twice a day
Control
Arm Description
Outcomes
Primary Outcome Measures
Number of sleep awakenings per night as assessed by the Brief Infant Sleep Questionnaire(BISQ)
Secondary Outcome Measures
Total amount of time subject is awake at night
Total amount of time subject is awake at night
Total amount of time subject is awake at night
Total amount of time subject is awake at night
Total amount of time subject is awake at night
Total amount of time subject is awake at night
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.
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.
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.
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.
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.
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.
Amount of time it takes for subject to fall asleep
Amount of time it takes for subject to fall asleep
Amount of time it takes for subject to fall asleep
Amount of time it takes for subject to fall asleep
Amount of time it takes for subject to fall asleep
Amount of time it takes for subject to fall asleep
Longest stretch of time the subject is asleep without waking up
Longest stretch of time the subject is asleep without waking up
Longest stretch of time the subject is asleep without waking up
Longest stretch of time the subject is asleep without waking up
Longest stretch of time the subject is asleep without waking up
Longest stretch of time the subject is asleep without waking up
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Number of participants with side effects
Full Information
NCT ID
NCT05479123
First Posted
July 27, 2022
Last Updated
July 28, 2022
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05479123
Brief Title
Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas
Official Title
Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Hemangioma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ter in die (TID)three times a day
Arm Type
Experimental
Arm Title
bis in die (BID)twice a day
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Propranolol three times a day
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propranolol twice a day
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Timolol
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of sleep awakenings per night as assessed by the Brief Infant Sleep Questionnaire(BISQ)
Time Frame
6 months from baseline
Secondary Outcome Measure Information:
Title
Total amount of time subject is awake at night
Time Frame
3 months from baseline
Title
Total amount of time subject is awake at night
Time Frame
6 months from baseline
Title
Total amount of time subject is awake at night
Time Frame
9 months from baseline
Title
Total amount of time subject is awake at night
Time Frame
12 months from baseline
Title
Total amount of time subject is awake at night
Time Frame
15 months from baseline
Title
Total amount of time subject is awake at night
Time Frame
18 months from baseline
Title
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)
Description
will be assessed categorically from very easy, somewhat easy, neither easy nor difficulty, somewhat difficult or very difficult.
Time Frame
3 months from baseline
Title
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)
Description
will be assessed categorically from very easy, somewhat easy, neither easy nor difficulty, somewhat difficult or very difficult.
Time Frame
6 months from baseline
Title
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)
Description
will be assessed categorically from very easy, somewhat easy, neither easy nor difficulty, somewhat difficult or very difficult.
Time Frame
9 months from baseline
Title
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)
Description
will be assessed categorically from very easy, somewhat easy, neither easy nor difficulty, somewhat difficult or very difficult.
Time Frame
12 months from baseline
Title
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)
Description
will be assessed categorically from very easy, somewhat easy, neither easy nor difficulty, somewhat difficult or very difficult.
Time Frame
15 months from baseline
Title
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)
Description
will be assessed categorically from very easy, somewhat easy, neither easy nor difficulty, somewhat difficult or very difficult.
Time Frame
18 months from baseline
Title
Amount of time it takes for subject to fall asleep
Time Frame
3 months from baseline
Title
Amount of time it takes for subject to fall asleep
Time Frame
6 months from baseline
Title
Amount of time it takes for subject to fall asleep
Time Frame
9 months from baseline
Title
Amount of time it takes for subject to fall asleep
Time Frame
12 months from baseline
Title
Amount of time it takes for subject to fall asleep
Time Frame
15 months from baseline
Title
Amount of time it takes for subject to fall asleep
Time Frame
18 months from baseline
Title
Longest stretch of time the subject is asleep without waking up
Time Frame
3 months from baseline
Title
Longest stretch of time the subject is asleep without waking up
Time Frame
6 months from baseline
Title
Longest stretch of time the subject is asleep without waking up
Time Frame
9 months from baseline
Title
Longest stretch of time the subject is asleep without waking up
Time Frame
12 months from baseline
Title
Longest stretch of time the subject is asleep without waking up
Time Frame
15 months from baseline
Title
Longest stretch of time the subject is asleep without waking up
Time Frame
18 months from baseline
Title
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Time Frame
3 months from baseline
Title
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Time Frame
6 months from baseline
Title
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Time Frame
9 months from baseline
Title
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Time Frame
12 months from baseline
Title
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Time Frame
15 months from baseline
Title
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Time Frame
18 months from baseline
Title
Number of participants with side effects
Time Frame
18 months from baseline
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew R Greives, MD
Phone
713-500-7275
Email
Matthew.R.Greives@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chioma Obinero
Phone
713-500-7216
Email
Chioma.G.Obinero@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew R Greives, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew R Greives, MD
Phone
713-500-7275
Email
Matthew.R.Greives@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Chioma Obinero
Phone
713-500-7216
Email
Chioma.G.Obinero@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas
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