A Novel Formulation of Pasteurized Maple Cough Syrup Compared With Placebo on Nocturnal Cough and Sleep Quality in Infants With Upper Respiratory Infection
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|ClinicalTrials.gov Identifier: NCT01588249|
Recruitment Status : Terminated (Revisiting product options)
First Posted : April 30, 2012
Last Update Posted : October 11, 2012
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|Condition or disease||Intervention/treatment||Phase|
|Cough Upper Respiratory Infection Nocturnal Cough||Dietary Supplement: Pasteurized maple syrup Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Novel Formulation of Pasteurized Maple Cough Syrup Compared With Placebo on Nocturnal Cough and Sleep Quality in Infants With Upper Respiratory Infection|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
|Experimental: Novel formulation of pasteurized maple cough syrup||
Dietary Supplement: Pasteurized maple syrup
|Placebo Comparator: Placebo||
Dietary Supplement: Placebo
- Change from baseline in cough frequency between the first night and the end of the second night. [ Time Frame: baseline and day 2 ]
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|Ages Eligible for Study:||up to 12 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Otherwise healthy male or female infant who is between 0 and 12 months of age.
- Presents to clinic with a URI characterized by the presence of rhinorrhea and cough for 7 or fewer days' duration.
- Patient is an appropriate candidate, in the judgment of the investigator, to participate in the study.
- Parents/caregivers provide an answer of at least "somewhat" (3 points on a 7-point Likert scale) for a minimum of 2 of the 3 questions related to nocturnal cough frequency, effect on child's sleep, and effect on parental/caregiver sleep based on the previous night's symptoms (see Section 11.0).
- Parent/legal authorized representative provides written informed consent for child to participate in study.
- Parent/caregiver who is willing and able to comply with study requirements.
- Signs or symptoms of a more treatable disease (eg, asthma, pneumonia, laryngotrachebronchitis, 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 to treat cough within 6 hours of bedtime on the evening prior to or on the day of enrollment. (Use of analgesic medications such as acetaminophen or ibuprofen is not exclusionary.)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588249
|United States, Utah|
|Willow Creek Pediatrics|
|Draper, Utah, United States|
|Families First Pediatrics|
|South Jordan, Utah, United States|
|Southwest Children's Clinic|
|West Jordan, Utah, United States|
|Responsible Party:||Zarbee's Inc.|
|Other Study ID Numbers:||
|First Posted:||April 30, 2012 Key Record Dates|
|Last Update Posted:||October 11, 2012|
|Last Verified:||October 2012|
Respiratory Tract Infections
Respiratory Tract Diseases
Signs and Symptoms, Respiratory