Clinical trial NCT00798824: 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
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infants
Keywords: tube feeding
premature infant
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2008-11-26
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Gestational age of the last required tube feed.
timeFrame: Last required tube feed
Secondary outcomes:
measure: Discharge date
timeFrame: Discharge date
measure: The amount suckled per day
timeFrame: Discharge date
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Intermediate Care Unit, Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Judy A Kublick, Grad student
role: PRINCIPAL_INVESTIGATOR
References: