NCT03497091

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

7 months

First QC Date

April 5, 2018

Last Update Submit

November 18, 2019

Conditions

Children Requiring Amino Acid-based Formula Tube FeedingEnteral Feeding Intolerance

Outcome Measures

Primary Outcomes (1)

  • Documented indication for formula use

    Medical diagnosis

    Up to 12 months before formula switch

Secondary Outcomes (6)

  • Body weight

    12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch

  • Length/height

    12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch

  • Formula volume consumption

    12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch

  • Stool frequency

    12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch

  • Stool consistency

    12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch

  • +1 more secondary outcomes

Study Arms (1)

Enteral Tube fed children

Enteral Formula

Other: Enteral Formula

Interventions

Enteral FormulaOTHER

Enteral Feeding with an amino acid-based formula

Enteral Tube fed children

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Medical records lacking information on consumption of an amino acid-based formula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Center for Rehabilitation Hospital

Oklahoma City, Oklahoma, 73008, United States

Location

Study Officials

  • Krysmaru AraujoTorres, MD

    Société des Produits Nestlé (SPN)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2018

First Posted

April 13, 2018

Study Start

June 15, 2018

Primary Completion

December 31, 2018

Study Completion

January 31, 2019

Last Updated

November 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)