A Study to Monitor the Use of an Amino Acid-Based Infant Formula
EAGLE
1 other identifier
observational
144
1 country
29
Brief Summary
To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2017
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2016
CompletedFirst Posted
Study publicly available on registry
November 2, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedFebruary 11, 2020
February 1, 2020
2 years
October 31, 2016
February 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
To assess the frequency and nature of adverse events in infants consuming a free amino acid based infant formula
4 months
Secondary Outcomes (1)
Clinical characteristics
4 months
Interventions
Patients who will be fed a free amino acid based infant formula
Eligibility Criteria
The intent of the program is to enroll infants consuming a free amino acid based infant formula identified in the US
You may qualify if:
- 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
You may not qualify if:
- \- Infants \<37 weeks of corrected gestation age (CGA) at time of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Pediatric Multicare West
Lakeside, Arizona, 85929, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
University of Arizona
Tucson, Arizona, 85724, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212, United States
Sutter Institute of Medical Research
Roseville, California, 95816, United States
Pioneer Clinical Research
Coconut Creek, Florida, 33066, United States
Children's Center for GI and Nutrition
Hollywood, Florida, 33021, United States
Childerns Health Center, PA
Homestead, Florida, 33030, United States
Homestead Medical Clinic
Miami, Florida, 33030, United States
Next Phase Research
Virginia Gardens, Florida, 33166, United States
Children's Gastroenterology Speciality
Glenview, Illinois, 60026, United States
Childrens Health Care
Wheeling, Illinois, 60090, United States
Springs Medical Research
Owensboro, Kentucky, 42303, United States
Acadiana Pediatric Gastro and Hep
Lafayette, Louisiana, 70508, United States
Tulane University Health Sciences Center
Metairie, Louisiana, 70001, United States
Conduct Clinical Trials
Flushing, New York, 11367, United States
The Feinstein Institute for Medical Research
Great Neck, New York, 11021, United States
State University of New York (SUNY)
Syracuse, New York, 13210, United States
Duke University
Durham, North Carolina, 27705, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
UH Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106, United States
University of Oklahoma, Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Milestones Pediatric Care
Tulsa, Oklahoma, 74146, United States
Cyn3rgy Research
Gresham, Oregon, 97030, United States
Invocare Clinical Research Center
West Columbia, South Carolina, 29169, United States
Childrens Health Center, PA
Marble Falls, Texas, 78654, United States
Southwest Children's Research Assoicaites
San Antonio, Texas, 78229, United States
Dixie Pediatrics
St. George, Utah, 84790, United States
Multicare Institute for research and Innovation
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Krysmaru AraujoTorres, MD
Nestle Health Science
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2016
First Posted
November 2, 2016
Study Start
January 1, 2017
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
February 11, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share