NCT00164957

Brief Summary

Background: Tube feeding had been found to be a cause of aspiration pneumonia. Continuous pump feeding at slower rates as compared to bolus feeding may be less associated with aspiration pneumonia. Methods: Randomized controlled trial Subjects: Patients expected to remain on tube feeding for 4 or more weeks Outcomes: 1\) pneumonia, 2) mortality

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2002

Longer than P75 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

Study Start

First participant enrolled

September 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 3, 2009

Status Verified

February 1, 2009

Enrollment Period

5.3 years

First QC Date

September 12, 2005

Last Update Submit

February 2, 2009

Conditions

Aspiration Pneumonia

Outcome Measures

Primary Outcomes (1)

  • pneumonia

    within 4 weeks

Secondary Outcomes (1)

  • mortality

    within 4 weeks

Interventions

continuous pump feedingDEVICE
intermittent bolus feedingOTHER

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients likely to need tube feeding for another 4 weeks

You may not qualify if:

  • Patients already on pump feeding.
  • Active sepsis: fever, abnormal white cell count
  • CXR shadowing
  • Chronic hypoxia (O2 saturation \<92% on room air)
  • Patients who have a history of recurrent self-extubation.
  • Short life expectancy (within weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Timothy CY Kwok, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

September 1, 2002

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 3, 2009

Record last verified: 2009-02

Locations

CN(1)