NCT02779335

Brief Summary

The purpose of this prospective study seeks to assess ability to achieve enteral feeding goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

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

March 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 21, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

March 18, 2016

Last Update Submit

October 20, 2016

Conditions

Enteral Nutrition

Keywords

tube-fedFormula TolerancePediatric Patients

Outcome Measures

Primary Outcomes (1)

  • Daily percentage of caloric nutritional goal met

    9 days

Secondary Outcomes (7)

  • Daily percentage of protein goal met

    9 days

  • Daily assessment of gastrointestinal tolerance - stool consistency

    9 days

  • Daily assessment of gastrointestinal tolerance- Stool frequency

    9 days

  • Daily assessment of gastrointestinal tolerance- Vomit

    9 days

  • Daily assessment of gastrointestinal tolerance - Flatulence

    9 days

  • +2 more secondary outcomes

Study Arms (1)

Enteral formula tube feeding

OTHER

Enteral fed children, ages 1-13, with establish enteral feeding access

Other: Enteral Formula

Interventions

Enteral FormulaOTHER

pediatric subjects will be fed a standard pediatric enteral formula tube feeding

Enteral formula tube feeding

Eligibility Criteria

Age1 Year - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • Currently tolerating enteral feeding
  • Has enteral access
  • Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 9 days
  • Having obtained his/her and/or his/her legal representative's informed consent

You may not qualify if:

  • Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
  • Lack of enteral access
  • Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)
  • Judged to be at risk for poor compliance to the study protocol
  • Lack of informed consent
  • Currently participating in another conflicting clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Center for GI and Nutrition

Hollywood, Florida, 33021, United States

Location

Study Officials

  • Gerard Minor, MMS, PA-C

    Children's Center for GI and Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

May 20, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 21, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)