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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
174
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.
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.
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).
The University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGNumber of sleep awakenings per night as assessed by the Brief Infant Sleep Questionnaire(BISQ)
Time frame: 6 months from baseline
Total amount of time subject is awake at night
Time frame: 3 months from baseline
Total amount of time subject is awake at night
Time frame: 6 months from baseline
Total amount of time subject is awake at night
Time frame: 9 months from baseline
Total amount of time subject is awake at night
Time frame: 12 months from baseline
Total amount of time subject is awake at night
Time frame: 15 months from baseline
Total amount of time subject is awake at night
Time frame: 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.
Time frame: 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.
Time frame: 6 months from baseline
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months from baseline
Amount of time it takes for subject to fall asleep
Time frame: 3 months from baseline
Amount of time it takes for subject to fall asleep
Time frame: 6 months from baseline
Amount of time it takes for subject to fall asleep
Time frame: 9 months from baseline
Amount of time it takes for subject to fall asleep
Time frame: 12 months from baseline
Amount of time it takes for subject to fall asleep
Time frame: 15 months from baseline
Amount of time it takes for subject to fall asleep
Time frame: 18 months from baseline
Longest stretch of time the subject is asleep without waking up
Time frame: 3 months from baseline
Longest stretch of time the subject is asleep without waking up
Time frame: 6 months from baseline
Longest stretch of time the subject is asleep without waking up
Time frame: 9 months from baseline
Longest stretch of time the subject is asleep without waking up
Time frame: 12 months from baseline
Longest stretch of time the subject is asleep without waking up
Time frame: 15 months from baseline
Longest stretch of time the subject is asleep without waking up
Time frame: 18 months from baseline
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Time frame: 3 months from baseline
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Time frame: 6 months from baseline
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Time frame: 9 months from baseline
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Time frame: 12 months from baseline
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Time frame: 15 months from baseline
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Time frame: 18 months from baseline
Number of participants with side effects
Time frame: 18 months from baseline