NCT05479123终止4 期
Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年6月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of Sleep Awakenings Per Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically diagnosed hemangiomas.
- •English or Spanish speaking only
排除标准
- •Parents who do not consent to the study.
- •Significant cardiac or pulmonary disease who are unable to tolerate oral propranolol
研究组 & 干预措施
ter in die (TID)three times a day
Experimental
干预措施: Propranolol three times a day (Drug)
bis in die (BID)twice a day
Experimental
干预措施: Propranolol twice a day (Drug)
Control
Active Comparator
干预措施: Timolol (Drug)
结局指标
主要结局
Number of Sleep Awakenings Per Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)
时间窗: 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).
次要结局
- 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)
- Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)(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)(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)(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)(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)(18 months from baseline)
- Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)(3 months from baseline)
- Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)(6 months from baseline)
- Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)(9 months from baseline)
- Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)(12 months from baseline)
- Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)(15 months from baseline)
- Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(18 months from baseline)
- 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)
研究者
Matthew Greives
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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