Growth and Tolerance of Young Infants Fed Infant Formulas

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01380886

Enrollment

209

Registered

2011-06-27

Start date

2011-06-30

Completion date

2011-12-31

Last updated

2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Newborn

Brief summary

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.

Interventions

OTHERexperimental infant formula with alternate protein source

experimental infant formula to be fed ad libitum

OTHERInfant formula powder

powdered infant formula to be fed ad libitum

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 8 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Weight gain	119 days

Secondary

Measure	Time frame	Description
gastrointestinal tolerance	119 days	Stool characteristics, number of stools per day, and number of feedings associated with spit up or vomit
Anthropometric variables	119 days	Length gain per day and head circumference gain per day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026