Infant Newborn
Conditions
Brief summary
The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.
Interventions
OTHERHuman Milk
ad lib
ad lib
OTHERMilk based standard infant formula
ad lib
Sponsors
Institute of Child Health
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 24 Hours
Healthy volunteers
Yes
Inclusion criteria
* good health * singleton birth with gestational age 37-42 weeks * infant's birth weight \>or = to 2500 grams * exclusive breastfeeding or exclusively formula feeding * within a defined geographical boundary * mother has no problems communicating in English
Exclusion criteria
* adverse maternal, fetal or infant medical history * congenital disease or malformation affecting growth or development * illness or social problems in mother or infant * temporary residents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight gain | 1- 365 days |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal tolerance | 1-365 days |
| Infant Anthropometrics | 1 - 365 days; 24 months |
Other
| Measure | Time frame |
|---|---|
| Vascular | at 24 months |
| Maternal Anthropometrics | at 24 months |
Countries
United Kingdom
Outcome results
None listed