A Study to Monitor the Use of an Amino… | Clinical Trial

Key information

Conditions

Cow's Milk Protein Allergy Digestive System Diseases Eosinophilia Eosinophilic Esophagitis Eosinophilic Gastrointestinal Disorders Esophageal Diseases Esophagitis Food Hypersensitivity Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Intestinal Diseases Leukocyte Disorders Malabsorption Syndromes Malabsorption/Maldigestion Metabolic Diseases Milk Hypersensitivity Multiple Food Allergies Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Short Bowel Syndrome

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Multicare West, Lakeside, Arizona, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Free amino acid infant formula

Other

Patients who will be fed a free amino acid based infant formula

Primary outcomes

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 outcomes

Clinical characteristics

Time frame: 4 months

To describe the demographic and clinical characteristics of infants fed a free amino acid based infant formula

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Acronym: EAGLE

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Nov 2, 2016
Registry last updated: Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed