NCT04247269

Brief Summary

Retrospective review of nutrition enteral formula data documented in medical records.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

August 21, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2022

Completed
Last Updated

June 9, 2022

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

January 23, 2020

Last Update Submit

June 7, 2022

Conditions

Enteral Feeding IntoleranceTube FeedingNutrition Disorder, Child

Outcome Measures

Primary Outcomes (1)

  • Nutrition Intake

    Assessment of enteral formula calorie and protein intake compared to nutrition prescription

    12 months

Secondary Outcomes (5)

  • Body weight

    12 months

  • Length/height

    12 months

  • Formula volume consumption

    12 months

  • Stool frequency

    12 months

  • Ventilator status

    12 months

Study Arms (2)

Enteral formula standard

Children fed an intact protein formula

Other: Enteral Tube Feeding

Enteral formula semi-elemental

Children fed a semi-elemental protein formula

Other: Enteral Tube Feeding

Interventions

Enteral Tube FeedingOTHER

Enteral tube feeding

Enteral formula semi-elementalEnteral formula standard

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Population studied retrospectively will be children with a history of enteral tube feeding in a home setting and meeting inclusion/exclusion criteria

You may qualify if:

  • Minimum 12 months enteral feeding
  • History of enteral feeding with intact or semi-elemental formula

You may not qualify if:

  • Medical records lacking enteral nutrition feeding use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Ohio Specialty Care

Columbus, Ohio, 43228, United States

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Krysmaru AraujoTorres, MD

    Société des Produits Nestlé (SPN)

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 30, 2020

Study Start

August 21, 2020

Primary Completion

June 2, 2022

Study Completion

June 2, 2022

Last Updated

June 9, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)