Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula
- Conditions
- Healthy Growth
- Interventions
- Other: Commercial Organic Infant FormulaOther: New Organic Infant Formula
- Registration Number
- NCT05783037
- Lead Sponsor
- Bobbie Baby, Inc
- Brief Summary
The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Therefore, this study also includes a group of breastfed babies for additional comparison.
- Detailed Description
This is a 16 week, double-blind, randomized, controlled trial designed to demonstrate that a new infant formula for term infants supports age-appropriate growth. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 335
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Commercial Organic Infant Formula Commercial Organic Infant Formula Commercially available organic infant formula for healthy term infants New Organic Infant Formula New Organic Infant Formula New organic infant formula for healthy term infants
- Primary Outcome Measures
Name Time Method Weight Gain Velocity Study Day 1 to Study Day 112 Weight Gain Velocity (g/day)
- Secondary Outcome Measures
Name Time Method Length Study Day 1 to Study Day 112 Length and Length Gain Velocity (cm)
Head Circumference Study Day 1 to Study Day 112 Head Circumference and Head Circumference Gain Velocity (cm)
Formula Intake Study Day 1 to Study Day 112 Formula Intake Volume (oz/kg/day)
Formula Intake (2) Study Day 1 to Study Day 112 Formula Intake Volume (oz/day)
Anthropometry Z-scores Study Day 1 to Study Day 112 Weight for age Z-score, Length for age Z-score, Weight for length Z-score, Head circumference for age Z-score
Trial Locations
- Locations (1)
SPRIM Pro
🇺🇸Indian Harbour Beach, Florida, United States