Growth and Tolerance
Conditions
Brief summary
To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.
Interventions
OTHERControl Formula
Feeding ad libitum
Feeding ad libitum
Feeding ad libitum
OTHERHuman Milk
Feeding ad libitum
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton from full term birth with a gestational age 37-42 weeks * Birth weight \> 2490 g (\ 5 lbs 8 oz) * Between 0 and 5 days of age * Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period * Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study, * Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study * No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
Exclusion criteria
* Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development * Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled * Treatment with antibiotics * Mother intends to use a combination of breast and formula feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Study Day (SD) 14 - 119 | Weight gain per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feeding Tolerance | Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits | % of feedings with spit up associated with feeding |
| Length | Study Day (SD) 1, 14, 28, 42, 84 and 119 visits | Length and interval length gain per day |
| Stool Characteristics | Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits | Stool consistency and number per day |
| Head Circumference | Study Day (SD) 1, 14, 28, 42, 84 and 119 visits | Head circumference (HC) and interval HC gain per day |
Other
| Measure | Time frame | Description |
|---|---|---|
| Study Formula Intake | Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits | Average volume of study formula intake and average number of study formula feedings per day |
| Oligosaccharides | Study Day (SD) 42 and 119 visits | Infant urine sample |
Countries
Puerto Rico, United States
Outcome results
None listed