Healthy Growth
Conditions
Keywords
Organic, Bobbie, Bobbie Baby, Weight, Growth, Breastfeeding, Infant Formula, Growth and Tolerance
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
Interventions
OTHERNew Organic Infant Formula
New organic infant formula fed daily ad libitum
OTHERCommercial Organic Infant Formula
Commercially available organic infant formula fed daily ad libitum
Sponsors
Bobbie Baby, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
Eligibility
Sex/Gender
ALL
Age
0 Days to 11 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Gain Velocity | Study Day 1 to Study Day 112 | Weight Gain Velocity (g/day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORThomas Lynch, MD
SPRIM Pro
Outcome results
None listed