Growth and Tolerance of Infants Fed Infant Formulas

Study Overview
=================
Brief Summary
-----------------
To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.

Official Title
-----------------
Growth and Tolerance of Young Infants Fed Infant Formulas

Conditions
-----------------
Growth and Tolerance

Intervention / Treatment
-----------------
* Other: Control Formula
* Other: Experimental Formula 1
* Other: Experimental Formula 2
* Other: Human Milk


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 5 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Human Milk<br>Reference group, breast feeding ad libitum | Other: Human Milk<br>* Feeding ad libitum<br>* Other names: Breast feeding group;|
| Active Comparator: Control Formula<br>Ready to feed infant formula, feed ad libitum | Other: Control Formula<br>* Feeding ad libitum<br>* Other names: Commercially available Infant Formula;|
| Experimental: Experimental Formula 1<br>Ready to feed infant formula with human milk oligosaccharides, feed ad libitum | Other: Experimental Formula 1<br>* Feeding ad libitum<br>|
| Experimental: Experimental Formula 2<br>Ready to feed infant formula with human milk oligosaccharides, feed ad libitum | Other: Experimental Formula 2<br>* Feeding ad libitum<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Weight gain per day | Study Day (SD) 14 - 119 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Characteristics | Stool consistency and number per day | Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits | 
| Feeding Tolerance | % of feedings with spit up associated with feeding | Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits | 
| Length | Length and interval length gain per day | Study Day (SD) 1, 14, 28, 42, 84 and 119 visits | 
| Head Circumference | Head circumference (HC) and interval HC gain per day | Study Day (SD) 1, 14, 28, 42, 84 and 119 visits |