| Primary | 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). | Data were only collected and analyzed for participants who completed the question at this timepoint. 0 participants completed this question in the bis in die (BID)twice a day arm and the control arm, therefore no data were collected or analyzed for these arms and it will not be collected in the future. | Posted | | Mean | Standard Deviation | sleep awakenings per night | | 6 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | | OG002 | Control | Timolol: 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). |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Secondary | 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. | Data were only collected and analyzed for participants who completed the question at this timepoint. | Posted | | Mean | Standard Deviation | minutes | | 3 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | | OG002 |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the question at this timepoint. 0 participants completed this question in the control arm, therefore no data were collected or analyzed for this arm and it will not be collected in the future. | Posted | | Mean | Standard Deviation | minutes | | 6 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the questionnaire at this timepoint. | Posted | | Mean | Standard Deviation | minutes | | 9 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | | OG002 |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the question at this timepoint. 0 participants from the bis in die (BID) twice a day arm and the control arm followed up at 12 months from baseline, therefore no data were analyzed or collected for these arms and they will not be collected in the future. | Posted | | Mean | Standard Deviation | minutes | | 12 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. |
|
| Secondary | 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. | This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 15 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. | Posted | | | | | | 15 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. |
|
| Secondary | 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. | This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 18 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. | Posted | | | | | | 18 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the questionnaire at this timepoint. | Posted | | Median | Inter-Quartile Range | score on a scale | | 3 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | | OG002 | Control | |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the questionnaire at this timepoint. 0 participants from the control arm followed up at 6 months from baseline, therefore no data were analyzed or collected for this arm and they will not be collected in the future. | Posted | | Median | Inter-Quartile Range | score on a scale | | 6 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the questionnaire at this timepoint. | Posted | | Median | Inter-Quartile Range | score on a scale | | 9 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | | OG002 | Control | |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the questionnaire at this timepoint. 0 participants from the bis in die (BID) twice a day arm and the control arm followed up at 12 months from baseline, therefore no data were analyzed or collected for these arms and they will not be collected in the future. | Posted | | Median | Inter-Quartile Range | score on a scale | | 12 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. |
|
| Secondary | 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. | This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 15 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. | Posted | | | | | | 15 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | |
|
| Secondary | 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. | This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 18 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. | Posted | | | | | | 18 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the questionnaire at this timepoint. | Posted | | Mean | Standard Deviation | minutes | | 3 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | | OG002 | Control |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the questionnaire at this timepoint. 0 participants from the control arm followed up at 6 months from baseline, therefore no data were analyzed or collected for this arms and they will not be collected in the future. | Posted | | Mean | Standard Deviation | minutes | | 6 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the questionnaire at this timepoint. | Posted | | Mean | Standard Deviation | minutes | | 9 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | | OG002 | Control |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the question at this timepoint. 0 participants from the bis in die (BID) twice a day arm and the control arm followed up at 12 months from baseline, therefore no data were analyzed or collected for these arms and they will not be collected in the future. | Posted | | Mean | Standard Deviation | minutes | | 12 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. |
|
| Secondary | 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. | This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 15 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. | Posted | | | | | | 15 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. |
|
| Secondary | 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. | This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 18 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. | Posted | | | | | | 18 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the question at this timepoint. | Posted | | Mean | Standard Deviation | hours | | 3 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | | OG002 | Control |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the question at this timepoint. 0 participants from the bis in die (BID) twice a day arm and the control arm followed up at 6 months from baseline, therefore no data were analyzed or collected for these arms and they will not be collected in the future. | Posted | | Mean | Standard Deviation | hours | | 6 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the question at this timepoint. | Posted | | Mean | Standard Deviation | hours | | 9 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | | OG002 | Control |
|
| Secondary | 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. | Data were only collected and analyzed for participants who completed the question at this timepoint. 0 participants from the bis in die (BID) twice a day arm and the control arm followed up at 12 months from baseline, therefore no data were analyzed or collected for these arms and they will not be collected in the future. | Posted | | Mean | Standard Deviation | hours | | 12 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. |
|
| Secondary | 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. | This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 15 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. | Posted | | | | | | 15 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. |
|
| Secondary | 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. | This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 18 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. | Posted | | | | | | 18 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. |
|
| Secondary | Clinical Response to Medication as Assessed by the Qualitative Clinical Assessment on Size, Color Changes of Hemangiomas | | This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 18 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. | Posted | | | | | | 18 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | | OG002 | Control | Timolol: 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). |
|
| Secondary | Number of Participants With Side Effects | | This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 18 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. | Posted | | | | | | 18 months from baseline | | | | ID | Title | Description |
|---|
| OG000 | Ter in Die (TID)Three Times a Day | Propranolol 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. | | OG001 | Bis in Die (BID)Twice a Day | Propranolol 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. | | OG002 | Control | Timolol: 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). |
|