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Retrospective Review of Amino Acid Formula Use at a Children's Center

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03497091
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Nestlé

Study Description
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Brief Summary:
This is a retrospective review of data documented in medical records.

Condition or disease Intervention/treatment
Children Requiring Amino Acid-based Formula Tube Feeding Enteral Feeding Intolerance Other: Enteral Formula

Detailed Description:
This is a retrospective review of data documented in medical records of patients consuming an amino-acid based enteral formula at a pediatric care facility in the United States.
Study Design
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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Review of Amino Acid Formula Use at a Children's Center
Actual Study Start Date : June 15, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : January 31, 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Enteral Tube fed children
Enteral Formula
 Other: Enteral Formula
Enteral Feeding with an amino acid-based formula


Outcome Measures
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Primary Outcome Measures :
  1. Documented indication for formula use [ Time Frame: Up to 12 months before formula switch ]
    Medical diagnosis


Secondary Outcome Measures :
  1. Body weight [ Time Frame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch ]
    Body weight in kilograms

  2. Length/height [ Time Frame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch ]
    Length or height (based on age) in centimeters

  3. Formula volume consumption [ Time Frame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch ]
    Average of 7 days

  4. Stool frequency [ Time Frame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch ]
    Average of 7 days

  5. Stool consistency [ Time Frame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch ]
    Average of 7 days

  6. Vomiting [ Time Frame: 12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch ]
    Average of 7 days


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population studied retrospectively will be children in a pediatric feeding center consuming an amino acid-based enteral fomula and meeting the inclusion/ exclusion criteria.
Criteria

Inclusion Criteria:

  • Consuming or with a history of consuming an amino acid-based formula

Exclusion Criteria:

  • Medical records lacking information on consumption of an amino acid-based formula
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497091


Locations
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United States, Oklahoma
Children's Center for Rehabilitation Hospital
Oklahoma City, Oklahoma, United States, 73008
Sponsors and Collaborators
Nestlé
Investigators
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Study Director: Krysmaru AraujoTorres, MD Nestlé
More Information
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03497091    
Other Study ID Numbers: 17.10.US.HCN
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No