A Study to Monitor the Use of an Amino Acid-Based Infant Formula
Overview
To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.
Study Type
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: January 2019
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
Interventions
- Other: Free amino acid infant formula
- Patients who will be fed a free amino acid based infant formula
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- Clinical characteristics
- Time Frame: 4 months
- To describe the demographic and clinical characteristics of infants fed a free amino acid based infant formula
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 1 Day
Maximum Age: 12 Months
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Krysmaru AraujoTorres, MD, Study Director, Nestle Health Science
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