Agave Cough Study - A Novel Formulation of Pasteurized Agave Cough Syrup Compared with Placebo and No Treatment on Nocturnal Cough and Sleep Quality in Infants and Toddlers with Upper Respiratory Infections (IRB# 41093)
- Principal Investigator: Ian M. Paul, M.D., M.Sc.
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. There is little evidence to support the use of over-the-counter (OTC) medicines for acute cough, particularly in younger children. Moreover, 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.
Due to the bothersome nature of cough to both children and their parents, other cultures have reported the use of alternative remedies such as honey to relieve symptoms (Pfeiffer 2005). A randomized, blinded study of the effect of a single dose of buckwheat honey, honey-flavored dextromethrophan, or no treatment administered 30 minutes prior to bedtime found that parents rated honey most favorably for symptomatic relief of their child's nocturnal cough and sleep difficulty due to URI. Unfortunately, children less than 1 year of age are precluded from using honey due to concerns of Clostridium botulinum spores found in honey that can lead to botulism in infants. Another product with similar properties to honey, agave nectar, has never been associated with botulism. Although no studies have formally evaluated the use of agave nectar for nocturnal cough associated with URI, the demulcent effect and sweet taste of agave nectar may provide some relief from cough in children.
-Otherwise healthy male or female infant who is 3 to <48 months of age.
-Presents to clinic with a URI characterized by the presence of rhinorrhea and cough for 7 or fewer days' duration.
-Parents/caregivers provide an answer of at least "moderate" (4 points on a 7-point (1-7 scoring) 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/caregiver who is willing and able to comply with study requirements.
Additional Study Details:
-Participants will be recruited from Penn State Hershey Children's Hospital outpatient pediatric clinics.
-Infants aged 2 months to <4 years who have URI characterized by rhinorrhea and cough for = 7 days duration will be approached for participation in the study.
-Parents/caregivers of children meeting study eligibility criteria will be asked by a trained study coordinator to complete an assessment of their child's cough and sleep difficulty on the previous night.
-In double-blind fashion, participants will be randomly assigned to 1 of 3 parallel groups, pasteurized agave cough syrup, placebo, or no treatment. A computer-generated randomization list prepared by the statistician will be used by the study coordinator to assign treatment groups. Parents/caregivers, patient care nurses, and participating clinicians will be blinded to study treatment assignment.
-A bag containing a pre-filled syringe with either agave syrup, placebo, or air will be provided to parents/caregivers.
-Parents/caregivers will be instructed to administer the treatment according to age-specific dosages outlined below within 30 minutes of the infant going to sleep for the night.
-A second survey asking the same questions as those answered at enrollment will be administered via a telephone interview to the same parent/caregiver the following day by a trained study coordinator.
-Participants will not return to the clinic for physical examination unless indicated by illness progression.
Pediatrics at 35 Hope Drive
Pediatric Clinical Research Office