A Study to Monitor the Use of an Amino Acid-Based Infant Formula
- Conditions
- Malabsorption/MaldigestionCow's Milk Protein AllergyShort Bowel SyndromeEosinophilic Gastrointestinal DisordersMultiple Food Allergies
- Registration Number
- NCT02953223
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief Summary
To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.
- Detailed Description
Prospective, post-market surveillance program to be conducted in the United States (US). Infant will be invited to enroll by their healthcare provider who recommends the use of a free amino acid based infant formula
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
-
Infants who use a free amino acid based Infant formula during their first year of life including:
- Those that are currently consuming the formula at the time of enrollment
- Those for whom consumption of the formula is planned
-
At least one parent/guardian is willing to provide written informed consent form (ICF) for participation in the surveillance program
- Infants <37 weeks of corrected gestation age (CGA) at time of enrollment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events 4 months To assess the frequency and nature of adverse events in infants consuming a free amino acid based infant formula
- Secondary Outcome Measures
Name Time Method Clinical characteristics 4 months To describe the demographic and clinical characteristics of infants fed a free amino acid based infant formula
Trial Locations
- Locations (29)
Children's Center for GI and Nutrition
🇺🇸Hollywood, Florida, United States
Sutter Institute of Medical Research
🇺🇸Roseville, California, United States
Childerns Health Center, PA
🇺🇸Homestead, Florida, United States
Childrens Health Care
🇺🇸Wheeling, Illinois, United States
Pediatric Multicare West
🇺🇸Lakeside, Arizona, United States
Pioneer Clinical Research
🇺🇸Coconut Creek, Florida, United States
Conduct Clinical Trials
🇺🇸Flushing, New York, United States
State University of New York (SUNY)
🇺🇸Syracuse, New York, United States
Milestones Pediatric Care
🇺🇸Tulsa, Oklahoma, United States
Cyn3rgy Research
🇺🇸Gresham, Oregon, United States
Dixie Pediatrics
🇺🇸Saint George, Utah, United States
Childrens Health Center, PA
🇺🇸Marble Falls, Texas, United States
Multicare Institute for research and Innovation
🇺🇸Tacoma, Washington, United States
Acadiana Pediatric Gastro and Hep
🇺🇸Lafayette, Louisiana, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
Tulane University Health Sciences Center
🇺🇸Metairie, Louisiana, United States
Invocare Clinical Research Center
🇺🇸West Columbia, South Carolina, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Homestead Medical Clinic
🇺🇸Miami, Florida, United States
Children's Gastroenterology Speciality
🇺🇸Glenview, Illinois, United States
Springs Medical Research
🇺🇸Owensboro, Kentucky, United States
The Feinstein Institute for Medical Research
🇺🇸Great Neck, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States
UH Rainbow Babies & Children's Hospital
🇺🇸Cleveland, Ohio, United States
University of Oklahoma, Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Southwest Children's Research Assoicaites
🇺🇸San Antonio, Texas, United States
Next Phase Research
🇺🇸Virginia Gardens, Florida, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States