Infantile HemangiomaPhase 4NCT05479123
Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas
A Phase 4 study testing Propranolol three times a day, Propranolol twice a day and Timolol in people with Infantile Hemangioma, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 months
- Conditions the study is for
- Infantile Hemangioma
- What is being tested?
- Propranolol three times a day, Propranolol twice a day and Timolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2022to 31 Jul 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinically diagnosed hemangiomas.
- English or Spanish speaking only
Who cannot join
- Parents who do not consent to the study.
- Significant cardiac or pulmonary disease who are unable to tolerate oral propranolol
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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
- Conditions
- Infantile Hemangioma
- Being tested
- Propranolol three times a day, Propranolol twice a day, Timolol
- Medical subject headings
- Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol three times a dayDrug
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.
Propranolol twice a dayDrug
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.
TimololDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| ter in die (TID)three times a day | Experimental | Not described Receives: Drug: Propranolol three times a day |
| bis in die (BID)twice a day | Experimental | Not described Receives: Drug: Propranolol twice a day |
| Control | Active comparator | Not described Receives: Drug: Timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months from baseline
Secondary outcomes (26)
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months from baseline
Clinical Response to Medication as Assessed by the Qualitative Clinical Assessment on Size, Color Changes of Hemangiomas
Measured: 18 months from baseline
Number of Participants With Side Effects
Measured: 18 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start23 Jun 2022
- Primary completion31 Mar 2025
- Study completion31 Jul 2025
Why it stopped: due to lack of recruitment and follow up compliance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infantile HemangiomaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Greives, The University of Texas Health Science Center, Houston
- Investigators
- Matthew R Greives, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479123
- Sponsor's protocol ID
- HSC-MS-22-0246
- Status last verified
- Mar 2026
- First submitted
- 27 Jul 2022
- Last updated
- 13 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas
- ClinicalTrials.gov ID
- NCT05479123
- Acronym / sponsor ID
- HSC-MS-22-0246
- Conditions
- Infantile Hemangioma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to lack of recruitment and follow up compliance
- Enrolment
- 52 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Posted 13 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ter in die (TID)three times a day | Experimental | Drug: Propranolol three times a day |
| bis in die (BID)twice a day | Experimental | Drug: Propranolol twice a day |
| Control | Active comparator | Drug: Timolol |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- clinically diagnosed hemangiomas.
- English or Spanish speaking only
Key exclusion criteria (2 listed)
- Parents who do not consent to the study.
- Significant cardiac or pulmonary disease who are unable to tolerate oral propranolol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol three times a dayPatients 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. | Drug | ter in die (TID)three times a day |
| Propranolol twice a dayPatients 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. | Drug | bis in die (BID)twice a day |
| TimololPatients 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). | Drug | Control |
Primary outcome
Number of Sleep Awakenings Per Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
Time frame: 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).
26 secondary outcomes
Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
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)
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)
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)
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)
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)
Time frame: 18 months from baseline
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
Time frame: 3 months from baseline
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
Time frame: 6 months from baseline
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
Time frame: 9 months from baseline
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
Time frame: 12 months from baseline
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
Time frame: 15 months from baseline
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew R Greives, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propranolol three times a day, Propranolol twice a day and Timolol in people with Infantile Hemangioma, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Sleep Awakenings Per Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ) (time frame: 6 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.