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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