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

U

University of Manitoba

Status

Completed

Conditions

Premature Infants

Treatments

Device: Oral gastric tube
Device: Nasogastric tube
Procedure: Indwelling nasogastric tube placement
Procedure: Intermittent orogastric tube placement

Study type

Interventional

Funder types

Other

Identifiers

NCT00798824
B2008:072

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

30 to 33 weeks old

Volunteers

Accepts 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Indwelling nasogastric tube placement
Active Comparator group
Treatment:
Procedure: Indwelling nasogastric tube placement
Device: Nasogastric tube
Intermittent orogastric tube placement
Active Comparator group
Treatment:
Procedure: Intermittent orogastric tube placement
Device: Oral gastric tube

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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