Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula

Launched by BOBBIE BABY, INC · Mar 23, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new organic cow's milk-based infant formula, called Bobbie's study formula, supports healthy growth in babies. The researchers want to see if babies who drink this new formula grow just as well as those who are fed with a standard cow's milk formula. They are also including a group of breastfed babies for comparison since breastfeeding is considered the best nutrition for infants.

To participate in this study, your baby should be a healthy newborn between 0 and 11 days old, born full-term (at least 37 weeks), and weigh between 5.5 and 9.9 pounds at birth. It's important that the caregiver has decided to either exclusively breastfeed or use infant formula and is willing to stick to that method throughout the study. Participants will need to keep track of their baby's feeding and health during the trial, but there are some exclusions, such as babies with certain medical conditions or those who have had allergies to cow's milk protein. If you decide to take part, you’ll be helping researchers understand how this new formula can support healthy growth in infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days)
• • Birth weight of ≥ 2,500 g and ≤ 4,500 g
• • Postnatal age ≤ 11 days at time of enrollment
• • Singleton
• • Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding)
• • Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, reporting of AEs, and urine collection)
• • Caregiver willing and able to sign IRB approved informed consent
• Exclusion Criteria:
• • Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
• • Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
• • Maternal, fetal, or infant medical history thought to have an impact on growth and/or development (substance abuse, positive HIV status, opioid exposure, or diabetes requiring insulin)
• • Infant receiving prescription medication
• • Infant with a known history of cow's milk protein allergy, excluding lactose intolerance
• • Infant who has been treated with antibiotics or medications that may impact growth, GI tolerance and/or development
• • Infant or family history (grandparent, parent, sibling) with known folate metabolism disorder
• • Caregiver intent to feed non-study formula or solid food during the study