Clinical trial NCT05479123: Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas
Official title: Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infantile Hemangioma
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 174
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility 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

Primary outcomes:
measure: Number of sleep awakenings per night as assessed by the Brief Infant Sleep Questionnaire(BISQ)
timeFrame: 6 months from baseline
Secondary outcomes:
measure: Total amount of time subject is awake at night
timeFrame: 3 months from baseline
measure: Total amount of time subject is awake at night
timeFrame: 6 months from baseline
measure: Total amount of time subject is awake at night
timeFrame: 9 months from baseline
measure: Total amount of time subject is awake at night
timeFrame: 12 months from baseline
measure: Total amount of time subject is awake at night
timeFrame: 15 months from baseline
measure: Total amount of time subject is awake at night
timeFrame: 18 months from baseline
measure: Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)
timeFrame: 3 months from baseline
measure: Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)
timeFrame: 6 months from baseline
measure: Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)
timeFrame: 9 months from baseline
measure: Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)
timeFrame: 12 months from baseline
measure: Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)
timeFrame: 15 months from baseline
measure: Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)
timeFrame: 18 months from baseline
measure: Amount of time it takes for subject to fall asleep
timeFrame: 3 months from baseline
measure: Amount of time it takes for subject to fall asleep
timeFrame: 6 months from baseline
measure: Amount of time it takes for subject to fall asleep
timeFrame: 9 months from baseline
measure: Amount of time it takes for subject to fall asleep
timeFrame: 12 months from baseline
measure: Amount of time it takes for subject to fall asleep
timeFrame: 15 months from baseline
measure: Amount of time it takes for subject to fall asleep
timeFrame: 18 months from baseline
measure: Longest stretch of time the subject is asleep without waking up
timeFrame: 3 months from baseline
measure: Longest stretch of time the subject is asleep without waking up
timeFrame: 6 months from baseline
measure: Longest stretch of time the subject is asleep without waking up
timeFrame: 9 months from baseline
measure: Longest stretch of time the subject is asleep without waking up
timeFrame: 12 months from baseline
measure: Longest stretch of time the subject is asleep without waking up
timeFrame: 15 months from baseline
measure: Longest stretch of time the subject is asleep without waking up
timeFrame: 18 months from baseline
measure: Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
timeFrame: 3 months from baseline
measure: Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
timeFrame: 6 months from baseline
measure: Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
timeFrame: 9 months from baseline
measure: Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
timeFrame: 12 months from baseline
measure: Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
timeFrame: 15 months from baseline
measure: Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
timeFrame: 18 months from baseline
measure: Number of participants with side effects
timeFrame: 18 months from baseline
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Matthew R Greives, MD
role: PRINCIPAL_INVESTIGATOR
References: