Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term

NCT ID: NCT00936637

Last Updated: 2009-07-10

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

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.

Detailed Description

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Conditions

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Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Extensively hydrolyzed infant formula

Group Type EXPERIMENTAL

Extensively hydrolyzed infant formula

Intervention Type OTHER

Interventions

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Extensively hydrolyzed infant formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* At birth:

* Healthy, term (37-42 weeks) infant
* Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
* At time of enrollment:

* \< or = 21 days post-natal age
* Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
* Exclusively formula fed
* Written informed consent of parent/guardian

Exclusion Criteria

* At the time of enrollment: partially human-milk fed; fed baby/solid foods
* Conditions requiring feedings other than those specified in the protocol
* Documented or suspected cow's milk allergy and/or soy protein allergies
* Major congenital deformities
* Suspected or documented systemic or congenital infections
* Evidence of cardiac, respiratory, hematological, gastrointestinal, or other systemic diseases
* Participation in any other clinical trial
Minimum Eligible Age

1 Day

Maximum Eligible Age

21 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Perrigo Nutritionals

INDUSTRY

Sponsor Role lead

Responsible Party

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PBM Products

Principal Investigators

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Cynthia M Barber, PhD

Role: STUDY_DIRECTOR

Perrigo Nutritionals

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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UVA Growth Study

Identifier Type: -

Identifier Source: org_study_id

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