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

Completed

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

• Registration Number: NCT02953223
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

To assess the frequency and nature of adverse events in infants 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

Study Timeline

• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-10-31
• Study First Posted: 2016-11-02
• Study Start: 2017-01
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events	4 months	To assess the frequency and nature of adverse events in infants consuming a free amino acid based infant formula

Secondary Outcome Measures

Name	Time	Method
Clinical characteristics	4 months	To describe the demographic and clinical characteristics of infants fed a free amino acid based infant formula

Trial Locations

Locations (29)

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

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