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

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ClinicalTrials.gov Identifier: NCT02953223
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

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

Condition or disease Intervention/treatment
Cow's Milk Protein Allergy Eosinophilic Gastrointestinal Disorders Malabsorption/Maldigestion Short Bowel Syndrome Multiple Food Allergies 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 [Patient Registry]
Estimated Enrollment : 20 participants
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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Free amino acid infant formula
    Patients who will be fed a free amino acid based infant formula


Primary Outcome Measures :
  1. 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 :
  1. Clinical characteristics [ Time Frame: 4 months ]
    To describe the demographic and clinical characteristics of infants fed a free amino acid based infant formula



Information from the National Library of Medicine

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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953223


Contacts
Contact: Pamela Cekola pamela.cekola@us.nestle.com

  Show 29 Study Locations
Sponsors and Collaborators
Nestlé
Investigators
Study Director: Juan Ochoa, MD Nestle Health Science

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02953223     History of Changes
Other Study ID Numbers: 15.04.US.HCN
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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