Clinical Trials
Formula Switching for Infants
IRB-HSR# 14281
Service:
Women's Health
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Category: Obstetrics/Gynecology
Adult Enrollment: No
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Minor Enrollment: Yes
Primary Investigator: James Sutphen
Contact Information
Contact: Margaret Steele-Kosowitz
Phone: 434.327.6967
E-mail: mjs8z@virginia.edu
Clinical Trial Description
University of Virginia is conducting a study of formula switching. Formulas included are FDA approved cows milk based infant formulas available at local stores.
The purpose of this study will be to look at how mothers/families switch formulas and whether or not switching formulas cause feeding issues or changes in feeding behaviors for infants.
- Healthy full-term infants age 1 to 12 months.
- Infants who are formula fed exclusively taking Similac Advance Early Shield, Enfamil Lipil Premium or PBM Nutritionals' milk based infant formula Prebiotic Immune Support.
Who is paying for this study?
- This study is being paid for by PBM, LLC.
How much time will the study take?
- You will need to come in for 3 visits in 11-14 days.
- You will also have at least one telephone contact.
- Each visit will take about 30 minutes.
- Your participation in this study is expected to last 11-14 days.
What will happen during the study?
- For this study, we will weigh, measure, and check head circumference of your infant at first study visit and weight at visit 2 and 3.
- We will ask you to feed your baby your current formula initially and then transition to the switch (study) formula and keep a daily diary. Switch (study) formula will be provided.
- We will ask you to bring all formula containers used during the study and your completed diary for review to each study visit.
Compensation:
- You will be paid a $25.00 gas card at enrollment and $125.00 upon successful completion of the study for a possible total of $150.00.
- The sponsor will offer a case of PBM infant formula at completion of study
Will being in this study cost you any money?
The study will cover the cost of the switch (study) formula and the study visits. The study does not pay for your regular well-baby visits or shots.
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