Effects of Early Nutrition on Growth

Abbott

Status: Completed

Conditions: Infant Newborn

Treatments: Other: Investigational infant formula; Other: Milk based standard infant formula; Other: Human Milk

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01300000

AK65

Details and patient eligibility

About

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.

Enrollment: 649 patients

Sex: All

Ages: 1 minute to 24 hours old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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649 participants in 3 patient groups

Human Milk

Active Comparator group

Description:

ad lib

Treatment:

Other: Human Milk

Milk based standard infant formula

Active Comparator group

Description:

ad lib

Treatment:

Other: Milk based standard infant formula

Milk based investigational infant formula

Experimental group

Description:

ad lib

Treatment:

Other: Investigational infant formula