Growth of Infants Fed Hydrolysate Formulas

NCT ID: NCT02006992

Last Updated: 2013-12-12

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

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2000-11-30

Brief Summary

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Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.

Detailed Description

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Conditions

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Growth and Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RTF Infant Formula 1

a ready to feed (RTF) extensively hydrolyzed infant formula fed ad lib.

Group Type ACTIVE_COMPARATOR

RTF Infant Formula

Intervention Type OTHER

a RTF extensively hydrolyzed infant formula

Powder Infant Formula 2

a powdered extensively hydrolyzed infant formula fed ad lib.

Group Type EXPERIMENTAL

Powder Infant Formula

Intervention Type OTHER

a powdered extensively hydrolyzed infant formula.

Interventions

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RTF Infant Formula

a RTF extensively hydrolyzed infant formula

Intervention Type OTHER

Powder Infant Formula

a powdered extensively hydrolyzed infant formula.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infants in good health.
* Singleton, term birth with a gestational age of 37 to 42 weeks.
* Birth weight of 2500 g (5 lb 8 oz) or greater.
* Between 0 and 9 days of age at enrollment.
* Not receiving vitamin or mineral supplements.

Exclusion Criteria

\- Maternal, fetal or perinatal medical history with potential for adverse effects on growth or development.
Maximum Eligible Age

9 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marlene Borschel, RD, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

Dreyer Medical Center

Aurora, Illinois, United States

Site Status

PediaResearch, LLC

Evansville, Indiana, United States

Site Status

The University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Kentucky Pediatric Research

Bardstown, Kentucky, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

NC Children's & Young Adults' Clinical Research Foundation

Chapel Hill, North Carolina, United States

Site Status

GrandView Medical Research

Sellersville, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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AJ57

Identifier Type: -

Identifier Source: org_study_id