Research Center: University of Colorado Anschutz Medical Campus
Location: 13123 E 16th Ave, Aurora, CO 80045, United States
Lead Researcher: Minghua Tang, PhD
IRB: #18-1317 This study has been reviewed and approved by the Colorado Multiple Institutional Review Board (COMIRB)
About the Study
Are you a parent planning to formula-feed your full-term, generally healthy newborn? Iron is an essential nutrient for your newborn, but did you know that it affects gut health too? Researchers from the University of Colorado Anschutz Medical Campus might have a great opportunity for you!
Researchers are looking at the relationship between the iron content in infant formula and your baby’s gut health and need participants to help with this important work. By participating, you may potentially get to help not only your own child, but the children of thousands of future parents. Remember that this is ultimately not about today, but about ensuring a healthier tomorrow for infants everywhere. Join now and see if you are eligible!
- Participants will be provided with Happy Baby Organic infant formula and formula preparation materials at no cost for the duration of the study. After completion, there are opportunities to continue working with the researchers on other Infant studies.
- Participants will be compensated up to $150 for participating in this study. Full compensation will only be provided to eligible participants who complete the study.
- Participants will be contributing valuable information that may benefit parents and infants in the future.
- Participants will be helping to advance medical research.
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
- Any information that you provide will be kept strictly confidential, except as required by law.
- Qualified health professionals will monitor your baby’s health as it relates to the study.
Who Can Participate?
- Parents who have a full-term child less than 4 weeks of age or who are pregnant and due before May 2024
- The child must be exclusively formula-fed and the parents must be open to feeding their child only the study formula
- The child must not have any health conditions that would affect their normal growth
- Must be willing to mix iron or placebo drops into the child’s formula for 4 months
- Must be able to attend a study visit at Children’s Hospital Colorado on the Anschutz Medical Campus
More Study Details
The study team will explain the research in its entirety but some details are:
- Participants and their babies will be randomly split into two groups (like flipping a coin)- one that receives an iron supplement and the other a placebo
- Participants, at the time of their delivery and before their discharge from the hospital, will have some information collected about them, such as:
- Blood will be drawn from the baby (only if the baby is less than 48 hours old)
- The participants’ baby will have their body weight, length, and head circumference measured
- Fecal samples will be collected from the participants’ baby
- Participants will be required to fill out two brief questionnaires of health and family histories
- At-home study visits will occur at enrollment, 1, 2, and 3 months of age. At these visits, the researcher will go over a health history questionnaire and measure your baby’s head circumference, length, and weight. They will also collect a soiled diaper.
- When the participants’ baby turns 4 months of age, both the participant and their baby will need to visit Children’s Hospital Colorado. This visit will involve head circumference, length, and weight measurements, as well as a blood draw.
About the Research Center
University of Colorado Anschutz Medical Campus
The University of Colorado Anschutz Medical Campus is the largest academic health center in the Rocky Mountain region at the forefront of transformative education, science, medicine, and healthcare. The campus includes the University of Colorado health professional schools, multiple centers and institutes, and two nationally ranked hospitals, CU Health University of Colorado Hospital and Children’s Hospital Colorado, which treat nearly 2 million patients each year. All interconnected, these organizations collaboratively improve the quality of patient care they deliver, the research they conduct, and the health professionals they train.
The researchers will take all safety precautions to keep both study participants and staff healthy and safe from respiratory illnesses.