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

NCT ID: NCT00798824

Last Updated: 2010-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Premature Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Indwelling nasogastric tube placement

Group Type ACTIVE_COMPARATOR

Indwelling nasogastric tube placement

Intervention Type PROCEDURE

The premature infant is fed with an indwelling nasogastric tube during feeding transition.

Nasogastric tube

Intervention Type DEVICE

Premature infants will be fed with a nasogastric tube in place and their feeding behaviors will be noted till discharge.

Intermittent orogastric tube placement

Group Type ACTIVE_COMPARATOR

Intermittent orogastric tube placement

Intervention Type PROCEDURE

The premature infant is fed with an intermittently placed orogastric tube during feeding transition.

Oral gastric tube

Intervention Type DEVICE

Premature infants will be fed with intermittent orogastric tube placement and their feeding behaviors will be noted till discharge.

Interventions

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Indwelling nasogastric tube placement

The premature infant is fed with an indwelling nasogastric tube during feeding transition.

Intervention Type PROCEDURE

Intermittent orogastric tube placement

The premature infant is fed with an intermittently placed orogastric tube during feeding transition.

Intervention Type PROCEDURE

Nasogastric tube

Premature infants will be fed with a nasogastric tube in place and their feeding behaviors will be noted till discharge.

Intervention Type DEVICE

Oral gastric tube

Premature infants will be fed with intermittent orogastric tube placement and their feeding behaviors will be noted till discharge.

Intervention Type DEVICE

Other Intervention Names

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Nasogastric tube Oral gastric tube

Eligibility Criteria

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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.
Minimum Eligible Age

30 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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University of Manitoba

Principal Investigators

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Judy A Kublick, Grad student

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Intermediate Care Unit, Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2008:072

Identifier Type: -

Identifier Source: org_study_id