Phase
Condition
Weight Loss
Diet And Nutrition
Treatment
Pediasure® Grow & Gain Protein Shake for Kids
Enfagrow® Neuropro Toddler Nutritional Drink
Clinical Study ID
Ages 12-36 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy toddlers 12-36 months of age with mild or moderate malnutrition will be defined by at least one of the following indicators:
Weight-for-length z-score between -1.0 and -2.9 for children less than 2 years ofage using the WHO growth standards; or
BMI z-score between -1 to -2.9 for children between 2 and 3 years of age using theCDC growth standards; or
Middle upper-arm circumference (MUAC) z-scores between -1 to -2.9 using the WHOgrowth references; or
Percentage of median ideal body weight of 70-89% (using the 50th percentile of theaforementioned growth standards).
Exclusion
Exclusion Criteria:
Toddlers currently on or with history of tube feeding or with chronic healthconditions that influence eating (e.g., food allergies, genetic disorders ordevelopmental disabilities, oral motor difficulties that require sensory or feedingtherapy).
Toddlers who were born at less than 34 weeks gestation, as they may have lingeringfeeding challenges.
Toddlers with gastroesophageal reflux disease (GERD) requiring medications orhydrolyzed formula or any type of esophageal disorders will be excluded.
Toddlers with a history of infant reflux will not be excluded. The PI will make thisdistinction after a detailed history and record review.
Families who do not speak English or Spanish in the home.
Toddlers with suspected malabsorption or conditions that increased metabolic demandssuch as congenital heart defects.
Toddlers who have a diagnosed allergy to cow's milk.
The PI will use their clinical discretion to ascertain patient eligibility.
Study Design
Connect with a study center
Children's Hospital Colorado
Aurora, Colorado 80045
United StatesSite Not Available
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