Text Size

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

This study has been completed.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00798824
First received: September 12, 2008
Last updated: October 12, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention
Premature Infants
 Procedure: Indwelling nasogastric tube placement
Procedure: Intermittent orogastric tube placement
Device: Nasogastric tube
Device: Oral gastric tube

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Impact of Nasogastric Indwelling Versus Oral Intermittent Tube Feeding Methods on Premature Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Gestational age of the last required tube feed. [ Time Frame: Last required tube feed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Discharge date [ Time Frame: Discharge date ] [ Designated as safety issue: No ]
  • The amount suckled per day [ Time Frame: Discharge date ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Indwelling nasogastric tube placement Procedure: Indwelling nasogastric tube placement
The premature infant is fed with an indwelling nasogastric tube during feeding transition.
Other Name: Nasogastric tube
Device: Nasogastric tube
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 Procedure: Intermittent orogastric tube placement
The premature infant is fed with an intermittently placed orogastric tube during feeding transition.
Other Name: Oral gastric tube
Device: Oral gastric tube
Premature infants will be fed with intermittent orogastric tube placement and their feeding behaviors will be noted till 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.

  Eligibility

Ages Eligible for Study:   30 Weeks to 33 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798824

Locations
Canada, Manitoba
Intermediate Care Unit, Health Sciences Centre
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Judy A Kublick, Grad student University of Manitoba
  More Information

No publications provided

Responsible Party: Judy Kublick, University of Manitoba
ClinicalTrials.gov Identifier: NCT00798824     History of Changes
Other Study ID Numbers: B2008:072
Study First Received: September 12, 2008
Last Updated: October 12, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
tube feeding
premature infant

ClinicalTrials.gov processed this record on June 18, 2013