Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders, Malabsorption/Maldigestion, Multiple Food Allergies, Short Bowel Syndrome
Conditions
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
Interventions
OTHERFree amino acid infant formula
Patients who will be fed a free amino acid based infant formula
Sponsors
Société des Produits Nestlé (SPN)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 4 months | To assess the frequency and nature of adverse events in infants consuming a free amino acid based infant formula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical characteristics | 4 months | To describe the demographic and clinical characteristics of infants fed a free amino acid based infant formula |
Countries
United States
Outcome results
None listed