Infants Fed a Hydrolyzed Infant Formula
Not Applicable
Completed
- Conditions
- Gastrointestinal Tolerance
- Interventions
- Other: Hydrolyzed protein infant formula with oligosaccharides
- Registration Number
- NCT05369494
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- Infant is 0 to 90 days of age at enrollment.
- Formula-fed Infant who is either experiencing persistent feeding intolerance, symptoms of suspected food protein allergy or currently consuming an extensively hydrolyzed formula (EHF) for symptoms of suspected food protein allergy, persistent feeding intolerance symptoms or other conditions where EHF is deemed an appropriate feeding by their health care professional
- Parent(s) of infants confirm their intention not to administer prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance, unless their infants are currently consuming and have been directed by their healthcare professional to continue their use during the study
- 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 (with the exception of Vitamin D supplements) to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
- 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) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study
Exclusion Criteria
- An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development
- Awareness of a positive drug screen in the mother or participant
- Suspected maternal substance abuse including alcohol
- Participation in another study that has not been approved as a concomitant study by AN
- Participant is receiving oral or inhaled steroids
- Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
- Participant has received an amino acid-based formula
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Product Hydrolyzed protein infant formula with oligosaccharides Infant formula product consumed ad libitum as instructed for approximately 28 days; Powder formula mixed to 20 kcal/fl. oz.
- Primary Outcome Measures
Name Time Method Weight Maintenance Study Day1 to Study Day 28 Change in weight for age z-score
- Secondary Outcome Measures
Name Time Method Gastrointestinal Tolerance Study Day1 to Study Day 28 Parent completed diary
Weight Study Day1 to Study Day 28 Weight gain per day in grams
Length Study Day1 to Study Day 28 Length gain per day in cm
Trial Locations
- Locations (7)
Gentle Pediatrics
🇺🇸Houston, Texas, United States
Meridian Clinical Research, LLC
🇺🇸Washington, District of Columbia, United States
AdventHealth Medical Group Pediatrics
🇺🇸Orange City, Florida, United States
Meridian Clinical Research 3259
🇺🇸Macon, Georgia, United States
Springs Medical Research
🇺🇸Owensboro, Kentucky, United States
Javara Inc.
🇺🇸Fayetteville, Georgia, United States
Meridian Clinical Research 3357
🇺🇸Charleston, South Carolina, United States