Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ter in die (TID)three times a day
|
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.
|
| Experimental: bis in die (BID)twice a day
|
Drug: 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.
|
| Active Comparator: Control
|
Drug: 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).
|
Outcome Measures
Primary Outcome Measures
- Number of sleep awakenings per night as assessed by the Brief Infant Sleep Questionnaire(BISQ) [6 months from baseline]
Secondary Outcome Measures
- Total amount of time subject is awake at night [3 months from baseline]
- Total amount of time subject is awake at night [6 months from baseline]
- Total amount of time subject is awake at night [9 months from baseline]
- Total amount of time subject is awake at night [12 months from baseline]
- Total amount of time subject is awake at night [15 months from baseline]
- Total amount of time subject is awake at night [18 months from baseline]
- Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ) [3 months from baseline]
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) [6 months from baseline]
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) [9 months from baseline]
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) [12 months from baseline]
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) [15 months from baseline]
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) [18 months from baseline]
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 [3 months from baseline]
- Amount of time it takes for subject to fall asleep [6 months from baseline]
- Amount of time it takes for subject to fall asleep [9 months from baseline]
- Amount of time it takes for subject to fall asleep [12 months from baseline]
- Amount of time it takes for subject to fall asleep [15 months from baseline]
- Amount of time it takes for subject to fall asleep [18 months from baseline]
- Longest stretch of time the subject is asleep without waking up [3 months from baseline]
- Longest stretch of time the subject is asleep without waking up [6 months from baseline]
- Longest stretch of time the subject is asleep without waking up [9 months from baseline]
- Longest stretch of time the subject is asleep without waking up [12 months from baseline]
- Longest stretch of time the subject is asleep without waking up [15 months from baseline]
- Longest stretch of time the subject is asleep without waking up [18 months from baseline]
- Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas [3 months from baseline]
- Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas [6 months from baseline]
- Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas [9 months from baseline]
- Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas [12 months from baseline]
- Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas [15 months from baseline]
- Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas [18 months from baseline]
- Number of participants with side effects [18 months from baseline]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
Investigators
- Principal Investigator: Matthew R Greives, MD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-22-0246