Clinical trial NCT02953223: A Study to Monitor the Use of an Amino Acid-Based Infant Formula
Official title: A Study to Monitor the Use of an Amino Acid-Based Infant Formula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cow's Milk Protein Allergy
Eosinophilic Gastrointestinal Disorders
Malabsorption/Maldigestion
Short Bowel Syndrome
Multiple Food Allergies
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 144
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The intent of the program is to enroll infants consuming a free amino acid based infant formula identified in the US

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- Infants \<37 weeks of corrected gestation age (CGA) at time of enrollment

Primary outcomes:
measure: Adverse events
timeFrame: 4 months
Secondary outcomes:
measure: Clinical characteristics
timeFrame: 4 months
Other outcomes:
Locations:
city: Lakeside
country: United States
facility: Pediatric Multicare West
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Roseville
country: United States
facility: Sutter Institute of Medical Research
state: California
city: Coconut Creek
country: United States
facility: Pioneer Clinical Research
state: Florida
city: Hollywood
country: United States
facility: Children's Center for GI and Nutrition
state: Florida
city: Homestead
country: United States
facility: Childerns Health Center, PA
state: Florida
city: Miami
country: United States
facility: Homestead Medical Clinic
state: Florida
city: Virginia Gardens
country: United States
facility: Next Phase Research
state: Florida
city: Glenview
country: United States
facility: Children's Gastroenterology Speciality
state: Illinois
city: Wheeling
country: United States
facility: Childrens Health Care
state: Illinois
city: Owensboro
country: United States
facility: Springs Medical Research
state: Kentucky
city: Lafayette
country: United States
facility: Acadiana Pediatric Gastro and Hep
state: Louisiana
city: Metairie
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Flushing
country: United States
facility: Conduct Clinical Trials
state: New York
city: Great Neck
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
city: Syracuse
country: United States
facility: State University of New York (SUNY)
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cleveland
country: United States
facility: UH Rainbow Babies & Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma, Health Sciences Center
state: Oklahoma
city: Tulsa
country: United States
facility: Milestones Pediatric Care
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: West Columbia
country: United States
facility: Invocare Clinical Research Center
state: South Carolina
city: Marble Falls
country: United States
facility: Childrens Health Center, PA
state: Texas
city: San Antonio
country: United States
facility: Southwest Children's Research Assoicaites
state: Texas
city: Saint George
country: United States
facility: Dixie Pediatrics
state: Utah
city: Tacoma
country: United States
facility: Multicare Institute for research and Innovation
state: Washington
Study officials:
affiliation: Nestle Health Science
name: Krysmaru AraujoTorres, MD
role: STUDY_DIRECTOR
References: