The Impact of Nasogastric Indwelling Versus Oral Intermittent Tube Feeding Methods on Premature Infants
October 12, 2010 updated by: University of Manitoba
This clinical pilot trial is being conducted to learn more about the infant's feeding behavior while being fed by indwelling nasogastric tube placement or by intermittent oral tube placement.
Healthy preterm infants who are transitioning from gavage to oral feedings via oral intermittent tube insertion may achieve full oral feeds by bottle/breast at an earlier gestational age than infants feeding with indwelling tubes and may be ready for earlier discharge.
Study Overview
Status
Completed
Conditions
Detailed Description
Independent feeding is often one of the last competencies that the premature infant must accomplish prior to discharge from hospital.
Feeding is a complex task for the premature infant to accomplish and it often takes many weeks for the infant to learn how to feed.
Therefore, tube feeding is required for the infant to ingest adequate nutrition during the transition from gavage feeding to oral feeding.
Both intermittent oral gavage tube placement and indwelling nasogastric tube placement are acceptable methods for feeding preterm infants.
However, it is not known which tube feeding method will support an expedited transition to oral feeding.
The choice of using one method over the other is currently based on the individual health care provider's opinion or historical institutional practices and insufficient evidence is available to guide tube feeding practices.
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada
- Intermediate Care Unit, Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 7 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Premature infants born between 30-33 and 6/7th weeks gestation are an appropriate size for gestational age, are not on Oxygen are of any race, sex and require tube feeding and are less than 34 and 3/7th weeks gestation.
Exclusion Criteria:
- infants with neurological abnormalities or insults, IVH greater than a grade of two, PVL, birth asphyxia, seizures, cord has less than 7.0 ph, chest compressions, infants who require abstinence scoring, infants with major congenital anomalies or major genetic anomalies that impact feeding ability such as diaphragmatic hernia and cleft palate, major cardiac defects, infants who develop necrotizing enterocolitis, infants who received more than 14 days of intubation or CPAP or oxygen by nasal prongs and infants of diabetic or alcoholic mothers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Indwelling nasogastric tube placement
|
The premature infant is fed with an indwelling nasogastric tube during feeding transition.
Other Names:
Premature infants will be fed with a nasogastric tube in place and their feeding behaviors will be noted till discharge.
|
|
Active Comparator: Intermittent orogastric tube placement
|
The premature infant is fed with an intermittently placed orogastric tube during feeding transition.
Other Names:
Premature infants will be fed with intermittent orogastric tube placement and their feeding behaviors will be noted till discharge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Gestational age of the last required tube feed.
Time Frame: Last required tube feed
|
Last required tube feed
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Discharge date
Time Frame: Discharge date
|
Discharge date
|
|
The amount suckled per day
Time Frame: Discharge date
|
Discharge date
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Judy A Kublick, Grad student, University of Manitoba
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
September 12, 2008
First Submitted That Met QC Criteria
November 25, 2008
First Posted (Estimate)
November 26, 2008
Study Record Updates
Last Update Posted (Estimate)
October 13, 2010
Last Update Submitted That Met QC Criteria
October 12, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2008:072
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.