Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents|
- Efficacy:Change in Cough Frequency based on parent responses to the Pediatric Cough Questionnaire [ Time Frame: Baseline (night 1) and End of night 2 ] [ Designated as safety issue: No ]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.
- Efficacy: Change in Response to Other symptom responses on the Pediatric Cough Questionnaire(parental report) [ Time Frame: Change from Baseline (night 1) to End of Second Night ] [ Designated as safety issue: No ]
Change from baseline (night 1) and the end of the second night for each of the remaining questionnaire items pertaining to cough and cold symptoms and the symptoms affect on sleep.
Parents/caregivers will complete a Pediatric Cough Questionnaire (a subjective parent report of cold symptoms) using a 0-6 point Likert scale with 0=not at all to 6=extremely often to assess cold symptoms.
- severity of cough
- bothersome nature of cough
- how much the cough affected the child's and parent's/caregiver's ability to sleep
- severity of stuffy nose
- severity of runny nose The same parent/caregiver that completed the questionnaire in the clinic will be asked to complete the questionnaire during the follow-up telephone call.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Colored, Flavored water
The placebo will be colored to approximate the reddish amber color of the agave syrup. The placebo will use the same flavoring used in the agave syrup. The placebo will be created in a GMP facility
Experimental: Agave Syrup
The formulation of pasteurized agave syrup consists of pasteurized agave syrup and natural flavoring.
Dietary Supplement: Agave Syrup
Other Name: Zarbee's Naturals Agave Baby Cough Syrup
No Intervention: Air-filled oral syringe
Air-filled oral syringe to match experimental and placebo arm
|Contact: Ian M Paul, MD, MScemail@example.com|
|Contact: Jessica SB Beiler, MPHfirstname.lastname@example.org|
|United States, Pennsylvania|
|Penn State Hershey Medical Center||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Ian M Paul, MD, MSc||Penn State University|