Growth of Infants Fed an Elemental Medical Food

Abbott

Status and phase: Completed; Phase 3

Conditions: Healthy Infants

Treatments: Other: Experimental Study Formula; Other: Control Study Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01699386

AH73

Details and patient eligibility

About

Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.

Enrollment: 213 patients

Sex: All

Ages: Under 9 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton, healthy infant
• Gestational age of 37 to 42 weeks
• Birth weight of 2500 grams or greater
• Age between birth and 9 days of age
• Parents agree to not administer mineral or vitamin supplements during the study period
• Parents agree to feed study formula exclusively for the duration of the study

Exclusion criteria

• Maternal, fetal or perinatal history which may have adverse effects on growth
• Multiple birth

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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213 participants in 2 patient groups

Control Study Formula

Active Comparator group

Description:

protein hydrolysate formula

Treatment:

Other: Control Study Formula

Experimental Study Formula

Experimental group

Description:

free-amino acid-based medical food

Treatment:

Other: Experimental Study Formula