Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Efficacy:Change in Cough Frequency based on parent responses to the Pediatric Cough Questionnaire
研究概览
简要总结
Cough is a frequent symptom in children and infants and is one of the most common reasons parents visit a healthcare provider for their child. The US Food and Drug Administration has issued a warning that over-the-counter cough and cold medicines including antihistamines, decongestants, anti-tussives, and expectorants should not be administered to children younger than 2 years of age due not only to lack of proven efficacy, but also because of important safety concerns. Honey, another method of soothing cough cannot be used in children <1 year due to concerns for infantile botulism. A preparation from agave syrup has been created to address the need for an infant cough syrup. Although no studies have formally evaluated the use of agave nectar for nocturnal cough associated with Upper Respiratory Infections, the demulcent effect and sweet taste of agave nectar may provide some relief from cough in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Otherwise healthy male or female infant who is 2 to <48 months of age.
- •presents with a non-specific acute cough for 7 or fewer days' duration.
- •Parents/legal authorized representative reporting at least moderate cough and cold symptoms.
- •Parent/legal authorized representative was in the home with the child on the night prior to enrollment and plans to be in the home with the child on the night when study treatment will be administered
- •Parent/legal authorized representative who is willing and able to comply with study requirements.
排除标准
- •Previous participation in this clinical trial
- •Gestational age at birth <35 weeks.
- •Signs or symptoms of a more treatable disease (eg, asthma, pneumonia, laryngotracheobronchitis, sinusitis, allergic rhinitis).
- •Diagnosis of influenza, bronchiolitis or respiratory syncytial virus (RSV).
- •History of reactive airways disease, asthma, or chronic lung disease.
- •Use of any medication or honey to treat cough within 6 hours of bedtime on the evening prior to or on the day of enrollment.
- •Presence of any significant disease including immunodeficiency, hepatic, renal,cardiovascular, or hematologic disease or any other health condition that, in the opinion of the investigator, would preclude participation in the study.
- •Known allergy to agave nectar or grape flavoring
结局指标
主要结局
Efficacy:Change in Cough Frequency based on parent responses to the Pediatric Cough Questionnaire
时间窗: Baseline (night 1) and End of night 2
Change from baseline in cough frequency between the first night and the end of the second night. Parents/caregivers will complete a Pediatric Cough Questionnaire (a subjective parent report of cough) using a 0-6 point Likert scale with 0=not at all to 6=extremely often to assess frequency of cough. The same parent/caregiver that completed the questionnaire in the clinic will be asked to complete the questionnaire during the follow-up telephone call.
次要结局
- Efficacy: Change in Response to Other symptom responses on the Pediatric Cough Questionnaire(parental report)(Change from Baseline (night 1) to End of Second Night)
研究者
Ian M. Paul, M.D., M.Sc.
Professor of Pediatrics and Public Health Sciences
Penn State University