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Trial record 14 of 34 for:    Recruiting, Not yet recruiting, Available Studies | "Malabsorption Syndromes" | United States

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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT02953223
First received: October 31, 2016
Last updated: July 19, 2017
Last verified: July 2017
  Purpose
To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.

Condition Intervention
Cow's Milk Protein Allergy Eosinophilic Gastrointestinal Disorders Malabsorption/Maldigestion Short Bowel Syndrome Multiple Food Allergies Other: Free amino acid infant formula

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: A Study to Monitor the Use of an Amino Acid-Based Infant Formula

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 4 months ]
    To assess the frequency and nature of adverse events in infants consuming a free amino acid based infant formula


Secondary Outcome Measures:
  • Clinical characteristics [ Time Frame: 4 months ]
    To describe the demographic and clinical characteristics of infants fed a free amino acid based infant formula


Estimated Enrollment: 20
Actual Study Start Date: January 2017
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Free amino acid infant formula
    Patients who will be 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

Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02953223

Contacts
Contact: Kemuel Reyes Kemuel.Reyes@us.nestle.com

Locations
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
United States, Arkansas
Applied Research Center of Arkansas Recruiting
Little Rock, Arkansas, United States, 72212
United States, Florida
Pioneer Clinical Research Recruiting
Coconut Creek, Florida, United States, 33066
Children's Center for GI and Nutrition Recruiting
Hollywood, Florida, United States, 33021
Childerns Health Center, PA Recruiting
Homestead, Florida, United States, 33030
Homestead Medical Clinic Recruiting
Miami, Florida, United States, 33030
United States, Illinois
Children's Gastroenterology Speciality Recruiting
Glenview, Illinois, United States, 60026
United States, Kentucky
Springs Medical Research Recruiting
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Acadiana Pediatric Gastro and Hep Recruiting
Lafayette, Louisiana, United States, 70508
United States, New York
Conduct Clinical Trials Recruiting
Flushing, New York, United States, 11367
United States, Oklahoma
Milestones Pediatric Care Recruiting
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Cyn3rgy Research Recruiting
Gresham, Oregon, United States, 97030
United States, South Carolina
Invocare Clinical Research Center Recruiting
West Columbia, South Carolina, United States, 29169
United States, Texas
Southwest Children's Research Assoicaites Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Nestlé
Investigators
Study Director: Juan Ochoa, MD Nestle Health Science
  More Information

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02953223     History of Changes
Other Study ID Numbers: 15.04.US.HCN
Study First Received: October 31, 2016
Last Updated: July 19, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Malabsorption Syndromes
Hypersensitivity
Food Hypersensitivity
Digestive System Diseases
Gastrointestinal Diseases
Short Bowel Syndrome
Immune System Diseases
Hypersensitivity, Immediate
Intestinal Diseases
Postoperative Complications
Pathologic Processes
Metabolic Diseases

ClinicalTrials.gov processed this record on August 23, 2017