The goal of this study is to demonstrate that babies fed Bubs infant formula grow at the same rate as those fed a commercially available cow milk formula. Such a study is a requirement by the FDA to allow a new infant formula into the USA market. Bubs makes infant formula that is currently available for sale in the United States through the FDA Infant Formula Enforcement Discretion Policy due to the infant formula shortage. Per FDA guidance, Bubs is conducting this study to support its application to continue to market and sell its products in the United States.

Your baby will receive one of four commercially available infant formulas for the entire study. All formula-fed babies in the study have a 25% chance of one of the 3 Bubs study products or an infant formula currently in the US market. This is totally random, which is a requirement for the study, so that the interpretation of the growth measurements is not influenced by the research team knowing which formula your baby received. Selecting one formula over the other is not possible.

The study takes place during your infants first 6 months of life. Babies must be enrolled and start on their study formula by 14 days old.

If you are currently expecting, you can enroll in our study starting at your 35th week of pregnancy. You will be reminded about our study when your due date is getting closer.

Babies must be full-term and under 14 days old to join the study.

Nope! You will need to come to Lincoln for the six growth monitoring visits to receive your formula but otherwise there are no geographic restrictions.

There are 6 growth monitoring visits during your baby's first 6 months of life. At those visits you will receive your formula and we have flexibile availability to meet your busy schedule!

Nope! There are no blood tests or other invasive testing to participate in the study. We simply measure growth parameters like weight, height, and head circumference during the study.

YES! The total compensation for completing the study is $300 spread out over six payments. Payments are made when study milestones are achieved by visiting the study doctor. If you are feeding your baby formula, you will receive the formula at no cost for the duration of the study as long as you visit the study doctor. If you successfully complete the study, you will receive an extra two-month supply of the study product.

On the same day as you come in to register. Once you register for the study, you will meet with a study doctor to complete enrollment before your baby is 14 days old. At the end of the visit you will receive your assigned study formula. You will receive enough formula to make sure you have enough until your next visit. You will continue to receive your formula at the scheduled visits. So long as you continue to visit the study doctor, you will receive all the formula your baby needs. If you successfully complete the study, you will receive an additional two-month supply.