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

Nestlé

Status: Completed

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

Treatments: Other: Free amino acid infant formula

Study type: Observational

Funder types: Industry

Identifiers

NCT02953223

15.04.US.HCN

Details and patient eligibility

About

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

Full 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

Enrollment: 144 patients

Sex: All

Ages: 1 day to 12 months old

Volunteers: No Healthy Volunteers

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