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

Société des Produits Nestlé (SPN)144 enrolled

Overview

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

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

144

Conditions

Cow's Milk Protein Allergy Eosinophilic Gastrointestinal Disorders Malabsorption/Maldigestion Short Bowel Syndrome Multiple Food Allergies

Interventions

Free amino acid infant formulaOTHER

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

Eligibility

Sex: ALLMin age: 1 DayMax age: 12 Months

Medical Language ↔ Plain English

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

Locations (29)

Outcomes

Primary Outcomes

Adverse events

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

Time frame: 4 months

Secondary Outcomes

Clinical characteristics

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

Time frame: 4 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Pediatric Multicare West

Lakeside, Arizona, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

University of Arizona

Tucson, Arizona, United States

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

Sutter Institute of Medical Research

Roseville, California, United States

Pioneer Clinical Research

Coconut Creek, Florida, United States

Children's Center for GI and Nutrition

Hollywood, Florida, United States

Childerns Health Center, PA

Homestead, Florida, United States

Homestead Medical Clinic

Miami, Florida, United States

Next Phase Research

Virginia Gardens, Florida, United States

...and 19 more locations