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
52
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
Number of Sleep Awakenings Per Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the number of times the child wakes during the night, as reported by the caregiver response to the question, "How many times does your child usually wake during the night?" from a single item of the Brief Infant Sleep Questionnaire (BISQ).
Time frame: 6 months from baseline
Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the total amount of time the child is usually awake during the night, as reported by the caregiver response, "How much total time during the night is your child usually awake (between when your child goes to bed and wakes for the day)?"Results are reported in minutes.
Time frame: 3 months from baseline
Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the total amount of time the child is usually awake during the night, as reported by the caregiver response to the question "How much total time during the night is your child usually awake (between when your child goes to bed and wakes for the day)?"Results are reported in minutes.
Time frame: 6 months from baseline
Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the total amount of time the child is usually awake during the night, as reported by the caregiver response to the question "How much total time during the night is your child usually awake (between when your child goes to bed and wakes for the day)?"Results are reported in minutes.
Time frame: 9 months from baseline
Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
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This item assesses the total amount of time the child is usually awake during the night, as reported by the caregiver response to the question "How much total time during the night is your child usually awake (between when your child goes to bed and wakes for the day)?"Results are reported in minutes.
Time frame: 12 months from baseline
Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the total amount of time the child is usually awake during the night, as reported by the caregiver response to the question "How much total time during the night is your child usually awake (between when your child goes to bed and wakes for the day)?"Results are reported in minutes.
Time frame: 15 months from baseline
Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the total amount of time the child is usually awake during the night, as reported by the caregiver response to the question "How much total time during the night is your child usually awake (between when your child goes to bed and wakes for the day)?"Results are reported in minutes.
Time frame: 18 months from baseline
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
The one item in the brief infant sleep questionnaire assesses difficulty falling asleep. The total score ranges from 1 to 5, a higher score indicates greater difficulty in falling asleep.
Time frame: 3 months from baseline
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
The one item in the brief infant sleep questionnaire assesses difficulty falling asleep. The total score ranges from 1 to 5, a higher score indicates greater difficulty in falling asleep.
Time frame: 6 months from baseline
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
The one item in the brief infant sleep questionnaire assesses difficulty falling asleep. The total score ranges from 1 to 5, a higher score indicates greater difficulty in falling asleep.
Time frame: 9 months from baseline
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
The one item in the brief infant sleep questionnaire assesses difficulty falling asleep. The total score ranges from 1 to 5, a higher score indicates greater difficulty in falling asleep.
Time frame: 12 months from baseline
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
The one item in the brief infant sleep questionnaire assesses difficulty falling asleep. The total score ranges from 1 to 5, a higher score indicates greater difficulty in falling asleep.
Time frame: 15 months from baseline
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
The one item in the brief infant sleep questionnaire assesses difficulty falling asleep. The total score ranges from 1 to 5, a higher score indicates greater difficulty in falling asleep.
Time frame: 18 months from baseline
Amount of Time it Takes for Subject to Fall Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the total amount of time it takes the child to fall asleep, as reported by the caregiver response to, "How long does it usually take your child to fall asleep?" Results are reported in minutes.
Time frame: 3 months from baseline
Amount of Time it Takes for Subject to Fall Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the total amount of time it takes the child to fall asleep, as reported by the caregiver response to, "How long does it usually take your child to fall asleep?" Results are reported in minutes.
Time frame: 6 months from baseline
Amount of Time it Takes for Subject to Fall Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the total amount of time it takes the child to fall asleep, as reported by the caregiver response to, "How long does it usually take your child to fall asleep?" Results are reported in minutes.
Time frame: 9 months from baseline
Amount of Time it Takes for Subject to Fall Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the total amount of time it takes the child to fall asleep, as reported by the caregiver response to, "How long does it usually take your child to fall asleep?" Results are reported in minutes.
Time frame: 12 months from baseline
Amount of Time it Takes for Subject to Fall Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the total amount of time it takes the child to fall asleep, as reported by the caregiver response to, "How long does it usually take your child to fall asleep?" Results are reported in minutes.
Time frame: 15 months from baseline
Amount of Time it Takes for Subject to Fall Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the total amount of time it takes the child to fall asleep, as reported by the caregiver response to, "How long does it usually take your child to fall asleep?" Results are reported in minutes.
Time frame: 18 months from baseline
Longest Stretch of Time the Subject is Asleep Without Waking up as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the longest stretch of time the child is asleep without waking up, as reported by the caregiver response to, "What is the longest stretch of time that your child is asleep during the night without waking up?" Results are reported in hours.
Time frame: 3 months from baseline
Longest Stretch of Time the Subject is Asleep Without Waking up as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the longest stretch of time the child is asleep without waking up, as reported by the caregiver response to, "What is the longest stretch of time that your child is asleep during the night without waking up?" Results are reported in hours.
Time frame: 6 months from baseline
Longest Stretch of Time the Subject is Asleep Without Waking up as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the longest stretch of time the child is asleep without waking up, as reported by the caregiver response to, "What is the longest stretch of time that your child is asleep during the night without waking up?" Results are reported in hours.
Time frame: 9 months from baseline
Longest Stretch of Time the Subject is Asleep Without Waking up as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the longest stretch of time the child is asleep without waking up, as reported by the caregiver response to, "What is the longest stretch of time that your child is asleep during the night without waking up?" Results are reported in hours.
Time frame: 12 months from baseline
Longest Stretch of Time the Subject is Asleep Without Waking up as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the longest stretch of time the child is asleep without waking up, as reported by the caregiver response to, "What is the longest stretch of time that your child is asleep during the night without waking up?" Results are reported in hours.
Time frame: 15 months from baseline
Longest Stretch of Time the Subject is Asleep Without Waking up as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
This item assesses the longest stretch of time the child is asleep without waking up, as reported by the caregiver response to, "What is the longest stretch of time that your child is asleep during the night without waking up?" Results are reported in hours.
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: 18 months from baseline
Number of Participants With Side Effects
Time frame: 18 months from baseline