Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula

Mead Johnson Nutrition

Status: Completed

Conditions: Healthy Term Infants Solely Formula Fed

Treatments: Other: Good Start Supreme with DHA and ARA; Other: Enfamil LIPIL with iron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00666120

3370-6

Details and patient eligibility

About

To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.

Hypothesize there will be no difference between formula groups.

Enrollment: 333 patients

Sex: All

Ages: 4 to 18 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton birth
• Term infant at birth
• Birth weight of 2500 g (5 lbs 8 oz) or more
• 4 - 18 days of age at Study Visit 1

Exclusion criteria

• History of underlying metabolic or chronic disease or congenital malformation
• Infant switched formulas more than one time between birth and Study Visit 1
• Known feeding problems at Study Visit 1

Trial design

333 participants in 2 patient groups

1

Active Comparator group

Description:

Cow's milk based infant formula

Treatment:

Other: Enfamil LIPIL with iron

2

Active Comparator group

Description:

Partially hydrolyzed cow's milk based infant formula

Treatment:

Other: Good Start Supreme with DHA and ARA