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

Study Overview
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Brief Summary
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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

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

Conditions
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Infantile Hemangioma

Intervention / Treatment
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* Drug: Propranolol three times a day
* Drug: Propranolol twice a day
* Drug: Timolol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ter in die (TID)three times a day<br> | Drug: Propranolol three times a day<br>* 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.<br>|
| Experimental: bis in die (BID)twice a day<br> | Drug: Propranolol twice a day<br>* 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.<br>|
| Active Comparator: Control<br> | Drug: Timolol<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sleep awakenings per night as assessed by the Brief Infant Sleep Questionnaire(BISQ) |  | 6 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | will be assessed categorically from very easy, somewhat easy, neither easy nor difficulty, somewhat difficult or very difficult. | 3 months from baseline | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |