Weight Gain
Conditions
Keywords
infant, formula, in-home
Brief summary
The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.
Interventions
OTHERNew Infant Formula
New infant formula fed daily ad libitum
OTHERCommercial Infant Formula
Commercially available infant formula fed daily ad libitum
Sponsors
IQVIA RDS Inc.
ObvioHealth
Jovie USA, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (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 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Normal term infant (37-42 weeks gestation at birth) * Infant \<15 (+3) days of age at first study feeding, Birth constitutes day 0 * Infant birth weight of ≥2500 g (5.5 lbs.) * Healthy Infant * 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, and reporting of AEs) * Caregiver willing and able to sign informed consent
Exclusion criteria
* Infant born in multiple birth (i.e., twins, triplets, etc.) * Infant born with medical complications (e.g., neurological, cerebral palsy, etc.) * Infant with family history (parents or siblings) of confirmed Milk or Soy allergies * 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 * Caregiver intent to feed non-study formula or solid food during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight gain from baseline to 16 weeks feeding | 16 weeks | Weight gain g/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length gain from baseline to 16 weeks feeding | 16 weeks | Length gain |
| Head Circumference gain from baseline to 16 weeks feeding | 16 weeks | Head Circumference gain |
| Volume of formula consumed during 3-consecutive day intervals | 16 weeks | Volume of formula consumed |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of AEs | 16 weeks | AEs reported during the study |
| Caregiver report of tolerance obtained during 3-consecutive day intervals | 16 weeks | Caregiver report of fussiness, gassiness, and spitting up |
| Caregiver report of stool characteristics obtained during 3-consecutive day intervals | 16 weeks | Caregiver report of stool consistency, color, and frequency |
| Stool collection for microbiome testing | 16 weeks | Stool collection for microbiome testing at week 16 of feeding |
Countries
United States
Outcome results
None listed