Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

Abbott

Status: Completed

Conditions: Gastrointestinal Tolerance

Study type: Observational

Funder types: Industry

Identifiers

NCT03597113

DA16

Details and patient eligibility

About

The purpose of this study is to evaluate the growth and compliance of an intended use population of infants receiving an extensively hydrolyzed infant formula.

Enrollment: 320 patients

Sex: All

Ages: Under 180 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infant is experiencing persistent feeding intolerance or allergy and diagnosed wtih Cow's Milk Protein Allergy (CMPA) or other condition where an extensively hydrolyzed formula is deemed appropriate by their healthcare professional
• Infants using OTC medications, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance
• Parent(s) of infants enrolled on prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids directed by their healthcare professional, confirm their intention to continue their use during the study until directed by their healthcare professional to discontinue.
• Infant is not receiving steroids.
• Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
• Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study
• Parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrollment through the duration of the study
• Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB)

Exclusion criteria

• Participation in another study that has not been approved as a concomitant study by AN