Skip to main content
OpenTrials
Completed

NCT Number: NCT03497091

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

This is a retrospective review of data documented in medical records.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Children Requiring Amino Acid-based Formula Tube Feeding Enteral Feeding Intolerance

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Center for Rehabilitation Hospital

Oklahoma City, Oklahoma, 73008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteral Formula

Other

Enteral Feeding with an amino acid-based formula

Primary outcomes

  1. Documented indication for formula use

    Time frame: Up to 12 months before formula switch

    Medical diagnosis

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 13, 2018
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.