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

Premature Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798824
• Other study ID #: B2008:072
• Status: Completed
• Phase: N/A
• First received: September 12, 2008
• Last updated: October 12, 2010
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2010
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Weeks to 33 Weeks

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Premature Birth
• Premature Infants

Intervention

Procedure:
• Indwelling nasogastric tube placement
The premature infant is fed with an indwelling nasogastric tube during feeding transition.
• Intermittent orogastric tube placement
The premature infant is fed with an intermittently placed orogastric tube during feeding transition.

Device:
• Nasogastric tube
Premature infants will be fed with a nasogastric tube in place and their feeding behaviors will be noted till discharge.
• Oral gastric tube
Premature infants will be fed with intermittent orogastric tube placement and their feeding behaviors will be noted till discharge.

Locations

Country	Name	City	State
Canada	Intermediate Care Unit, Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational age of the last required tube feed.		Last required tube feed	No
Secondary	Discharge date		Discharge date	No
Secondary	The amount suckled per day		Discharge date	No