CompletedNot Applicable

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

United States144 participantsStarted 2017-01

Plain-language summary

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

Who can participate

Age range1 Day – 12 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Adverse events

Timeframe: 4 months

Trial details

NCT IDNCT02953223

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-01

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