A Study to Monitor the Use of an Amino Acid-Based Infant Formula

NCT ID: NCT02953223

Last Updated: 2020-02-11

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

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-01-31

Brief Summary

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To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.

Detailed Description

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Prospective, post-market surveillance program to be conducted in the United States (US). Infant will be invited to enroll by their healthcare provider who recommends the use of a free amino acid based infant formula

Conditions

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Cow's Milk Protein Allergy Eosinophilic Gastrointestinal Disorders Malabsorption/Maldigestion Short Bowel Syndrome Multiple Food Allergies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Free amino acid infant formula

Patients who will be fed a free amino acid based infant formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infants who use a free amino acid based Infant formula during their first year of life including:

* Those that are currently consuming the formula at the time of enrollment
* Those for whom consumption of the formula is planned
* At least one parent/guardian is willing to provide written informed consent form (ICF) for participation in the surveillance program

Exclusion Criteria

\- Infants \<37 weeks of corrected gestation age (CGA) at time of enrollment
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krysmaru AraujoTorres, MD

Role: STUDY_DIRECTOR

Nestle Health Science

Locations

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Pediatric Multicare West

Lakeside, Arizona, United States

Site Status

Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status

University of Arizona

Tucson, Arizona, United States

Site Status

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

Site Status

Sutter Institute of Medical Research

Roseville, California, United States

Site Status

Pioneer Clinical Research

Coconut Creek, Florida, United States

Site Status

Children's Center for GI and Nutrition

Hollywood, Florida, United States

Site Status

Childerns Health Center, PA

Homestead, Florida, United States

Site Status

Homestead Medical Clinic

Miami, Florida, United States

Site Status

Next Phase Research

Virginia Gardens, Florida, United States

Site Status

Children's Gastroenterology Speciality

Glenview, Illinois, United States

Site Status

Childrens Health Care

Wheeling, Illinois, United States

Site Status

Springs Medical Research

Owensboro, Kentucky, United States

Site Status

Acadiana Pediatric Gastro and Hep

Lafayette, Louisiana, United States

Site Status

Tulane University Health Sciences Center

Metairie, Louisiana, United States

Site Status

Conduct Clinical Trials

Flushing, New York, United States

Site Status

The Feinstein Institute for Medical Research

Great Neck, New York, United States

Site Status

State University of New York (SUNY)

Syracuse, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Site Status

UH Rainbow Babies & Children's Hospital

Cleveland, Ohio, United States

Site Status

University of Oklahoma, Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Milestones Pediatric Care

Tulsa, Oklahoma, United States

Site Status

Cyn3rgy Research

Gresham, Oregon, United States

Site Status

Invocare Clinical Research Center

West Columbia, South Carolina, United States

Site Status

Childrens Health Center, PA

Marble Falls, Texas, United States

Site Status

Southwest Children's Research Assoicaites

San Antonio, Texas, United States

Site Status

Dixie Pediatrics

St. George, Utah, United States

Site Status

Multicare Institute for research and Innovation

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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15.04.US.HCN

Identifier Type: -

Identifier Source: org_study_id

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