Followup of Infants Fed Non-routine Infant Formula

NCT ID: NCT00665938

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to compare physical development of infants fed one of three study formulas.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Infant formula

Intervention Type OTHER

Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL)

Arm 2. partially hydrolyzed infant formula with probiotics

Arm 3. extensively hydrolyzed infant formula with probiotics

2

Group Type EXPERIMENTAL

Infant formula

Intervention Type OTHER

Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL)

Arm 2. partially hydrolyzed infant formula with probiotics

Arm 3. extensively hydrolyzed infant formula with probiotics

3

Group Type EXPERIMENTAL

Infant formula

Intervention Type OTHER

Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL)

Arm 2. partially hydrolyzed infant formula with probiotics

Arm 3. extensively hydrolyzed infant formula with probiotics

Interventions

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Infant formula

Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL)

Arm 2. partially hydrolyzed infant formula with probiotics

Arm 3. extensively hydrolyzed infant formula with probiotics

Intervention Type OTHER

Other Intervention Names

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No other names are applicable to the 3 intervention arms

Eligibility Criteria

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Inclusion Criteria

* Completed Study 3369-5

Exclusion Criteria

* None
Minimum Eligible Age

4 Months

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Mead Johnson

Principal Investigators

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Deolinda Scalabrin, MD

Role: STUDY_DIRECTOR

Mead Johnson Nutrition

Other Identifiers

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3369-6

Identifier Type: -

Identifier Source: secondary_id

3369-6

Identifier Type: -

Identifier Source: org_study_id

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