Growth and Tolerance of Young Infants Fed Infant Formulas

Abbott

Status and phase: Completed; Phase 3

Conditions: Infant Newborn

Treatments: Other: Infant formula powder; Other: experimental infant formula with alternate protein source

Study type: Interventional

Funder types: Industry

Identifiers

NCT01380886

AK92

Details and patient eligibility

About

This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.

Enrollment: 209 patients

Sex: All

Ages: Under 8 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy infant
• full term
• birth weight > 2490 g
• 0 to 8 days of age
• parent/physician agree to not use medications affecting tolerance/growth
• parent agrees to sole source feeding of study formula
• parent agrees to not use vitamin/mineral supplements
• parent has signed consent/HIPAA authorization

Exclusion criteria

• any maternal, fetal, or infant history affecting growth and tolerance
• participation in any other study not preapproved by Abbott

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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209 participants in 2 patient groups

Infant formula, alternate protein source

Experimental group

Description:

Experimental infant formula with alternate protein source

Treatment:

Other: experimental infant formula with alternate protein source

Infant formula powder

Active Comparator group

Description:

Infant formula powder

Treatment:

Other: Infant formula powder