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The Impact of Nasogastric Indwelling Versus Oral Intermittent Tube Feeding Methods on Premature Infants

Primary Purpose

Premature Infants

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Indwelling nasogastric tube placement
Intermittent orogastric tube placement
Nasogastric tube
Oral gastric tube
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Infants focused on measuring tube feeding, premature infant

Eligibility Criteria

30 Weeks - 33 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Intermediate Care Unit, Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Indwelling nasogastric tube placement

Intermittent orogastric tube placement

Arm Description

Outcomes

Primary Outcome Measures

Gestational age of the last required tube feed.

Secondary Outcome Measures

Discharge date
The amount suckled per day

Full Information

First Posted
September 12, 2008
Last Updated
October 12, 2010
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT00798824
Brief Title
The Impact of Nasogastric Indwelling Versus Oral Intermittent Tube Feeding Methods on Premature Infants
Official Title
The Impact of Nasogastric Indwelling Versus Oral Intermittent Tube Feeding Methods on Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infants
Keywords
tube feeding, premature infant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Indwelling nasogastric tube placement
Arm Type
Active Comparator
Arm Title
Intermittent orogastric tube placement
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Indwelling nasogastric tube placement
Other Intervention Name(s)
Nasogastric tube
Intervention Description
The premature infant is fed with an indwelling nasogastric tube during feeding transition.
Intervention Type
Procedure
Intervention Name(s)
Intermittent orogastric tube placement
Other Intervention Name(s)
Oral gastric tube
Intervention Description
The premature infant is fed with an intermittently placed orogastric tube during feeding transition.
Intervention Type
Device
Intervention Name(s)
Nasogastric tube
Intervention Description
Premature infants will be fed with a nasogastric tube in place and their feeding behaviors will be noted till discharge.
Intervention Type
Device
Intervention Name(s)
Oral gastric tube
Intervention Description
Premature infants will be fed with intermittent orogastric tube placement and their feeding behaviors will be noted till discharge.
Primary Outcome Measure Information:
Title
Gestational age of the last required tube feed.
Time Frame
Last required tube feed
Secondary Outcome Measure Information:
Title
Discharge date
Time Frame
Discharge date
Title
The amount suckled per day
Time Frame
Discharge date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy A Kublick, Grad student
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermediate Care Unit, Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

The Impact of Nasogastric Indwelling Versus Oral Intermittent Tube Feeding Methods on Premature Infants

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