NCT01469117

Brief Summary

This is a single center, prospective, non-randomized, uncontrolled, observational study of the use of an enteral nutrition product in pediatric patients with developmental disabilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

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

Study Start

First participant enrolled

November 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 7, 2014

Status Verified

August 1, 2014

Enrollment Period

1.2 years

First QC Date

November 8, 2011

Last Update Submit

August 6, 2014

Conditions

Developmental Disabilities

Keywords

Developmental disabilitiesEnteral NutritionTube feedingNutrition support

Outcome Measures

Primary Outcomes (1)

  • Time to feeding goal achievement

    up to 14 days

Secondary Outcomes (4)

  • Gastrointestinal measures assessment

    up to 21 days

  • Percentage of nutrition goal met

    daily up to 21 days

  • Serum biochemical markers assessment

    baseline and completion of study

  • Assessment of frequency and nature of adverse events

    daily up to 21 days

Study Arms (1)

Pediatric developmental disabilities

Children aged 1-13 years old with development disabilities, requiring enteral tube feeding for at least 14 days

Other: enteral formula

Interventions

enteral formulaOTHER

Complete feeding of study enteral formula, route and regimen prescribed by the physician

Pediatric developmental disabilities

Eligibility Criteria

Age1 Year - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients with developmental disabilities

You may qualify if:

  • Child aged 1-13 years old with development disabilities
  • Currently tolerating enteral feeding
  • Requiring nutritional management to meet 50-90th% weight for age on the Kennedy Kreiger Growth Charts
  • Requires enteral tube feeding for at least 14 days.

You may not qualify if:

  • Unable to access gastrointestinal tract for feeding via tube
  • Other condition which contraindicates tube feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Center

Bethany, Oklahoma, 73008, United States

Location

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Darin Brannan, MD

    The Children's Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2011

First Posted

November 10, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 7, 2014

Record last verified: 2014-08

Locations

US(1)