The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants

Mead Johnson Nutrition

Status: Completed

Conditions: Growth of Term Infants

Treatments: Other: Control: Marketed routine infant formula; Other: An investigational infant formula containing an alternate source of DHA

Study type: Interventional

Funder types: Industry

Identifiers

NCT02132663

3386-1

Details and patient eligibility

About

This clinical trial will evaluate an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant formula.

Enrollment: 315 estimated patients

Sex: All

Ages: 10 to 14 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton, 10-14 days of age at randomization
• Term infant with birth weight of a minimum of 2500 grams
• Solely formula fed
• Signed Informed Consent and Protected Health Information

Exclusion criteria

• History of underlying metabolic or chronic disease or immunocompromised
• Feeding difficulties or formula intolerance

Trial design

315 participants in 2 patient groups

Infant formula containing an alternate source of DHA

Experimental group

Treatment:

Other: An investigational infant formula containing an alternate source of DHA

Marketed routine infant formula

Active Comparator group

Treatment:

Other: Control: Marketed routine infant formula