A Study to Monitor the Use of an Amino Acid-Based Infant Formula
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Gastrointestinal, Nephrology, Digestive Disease |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/24/2018 |
| Start Date: | January 2017 |
| End Date: | December 2018 |
To assess the frequency and nature of adverse events in infants fed a free amino acid based
infant formula.
infant formula.
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
Infant will be invited to enroll by their healthcare provider who recommends the use of a
free amino acid based infant formula
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
We found this trial at
29
sites
4720 South I-10 Service Road West
Metairie, Louisiana 70001
Metairie, Louisiana 70001
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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University of Arizona The University of Arizona is a premier, public research university. Established in...
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