A Study to Monitor the Use of an Amino Acid-Based Infant Formula (EAGLE)

To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.

Study Overview

• Status: Completed
• Conditions: Short Bowel Syndrome; Cow's Milk Protein Allergy; Eosinophilic Gastrointestinal Disorders; Malabsorption/Maldigestion; Multiple Food Allergies
• Intervention / Treatment: Other: Free amino acid 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

• Study Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Lakeside, Arizona, United States, 85929
      • Pediatric Multicare West
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Arkansas
  • California
    • Roseville, California, United States, 95816
      • Sutter Institute of Medical Research
  • Florida
    • Coconut Creek, Florida, United States, 33066
      • Pioneer Clinical Research
    • Hollywood, Florida, United States, 33021
      • Children's Center for GI and Nutrition
    • Homestead, Florida, United States, 33030
      • Childerns Health Center, PA
    • Miami, Florida, United States, 33030
      • Homestead Medical Clinic
    • Virginia Gardens, Florida, United States, 33166
      • Next Phase Research
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Children's Gastroenterology Speciality
    • Wheeling, Illinois, United States, 60090
      • Childrens Health Care
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Springs Medical Research
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Acadiana Pediatric Gastro and Hep
    • Metairie, Louisiana, United States, 70001
      • Tulane University Health Sciences Center
  • New York
    • Flushing, New York, United States, 11367
      • Conduct Clinical Trials
    • Great Neck, New York, United States, 11021
      • The Feinstein Institute for Medical Research
    • Syracuse, New York, United States, 13210
      • State University of New York (SUNY)
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • UH Rainbow Babies & Children's Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma, Health Sciences Center
    • Tulsa, Oklahoma, United States, 74146
      • Milestones Pediatric Care
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Cyn3rgy Research
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Invocare Clinical Research Center
  • Texas
    • Marble Falls, Texas, United States, 78654
      • Childrens Health Center, PA
    • San Antonio, Texas, United States, 78229
      • Southwest Children's Research Assoicaites
  • Utah
    • Saint George, Utah, United States, 84790
      • Dixie Pediatrics
  • Washington
    • Tacoma, Washington, United States, 98405
      • Multicare Institute for Research and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	To assess the frequency and nature of adverse events in infants consuming a free amino acid based infant formula	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical characteristics	To describe the demographic and clinical characteristics of infants fed a free amino acid based infant formula	4 months

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Study Director: Krysmaru AraujoTorres, MD, Nestle Health Science

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Immune System Diseases; Hypersensitivity, Immediate; Postoperative Complications; Intestinal Diseases; Hypersensitivity; Milk Hypersensitivity; Gastrointestinal Diseases; Digestive System Diseases; Food Hypersensitivity; Malabsorption Syndromes; Short Bowel Syndrome
• Other Study ID Numbers: 15.04.US.HCN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO