Infantile Hemangioma
Conditions
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
Interventions
DRUGPropranolol 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.
DRUGPropranolol 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.
DRUGTimolol
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).
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sleep Awakenings Per Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ) | 6 months from baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ) | 3 months from baseline | 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. |
| Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ) | 3 months from baseline | 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. |
| Amount of Time it Takes for Subject to Fall Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ) | 3 months from baseline | 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. |
| Longest Stretch of Time the Subject is Asleep Without Waking up as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ) | 3 months from baseline | 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. |
| 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 | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatthew R Greives, MD
The University of Texas Health Science Center, Houston
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 19.3 months STANDARD_DEVIATION 6.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 16 |
| other Total, other adverse events | 0 / 18 | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 16 |
Outcome results
None listed