The Impact of Nasogastric Indwelling Versus Oral Intermittent Tube Feeding Methods on Premature Infants
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 12, 2008
CompletedFirst Posted
Study publicly available on registry
November 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedOctober 13, 2010
October 1, 2010
1.3 years
September 12, 2008
October 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gestational age of the last required tube feed.
Last required tube feed
Secondary Outcomes (2)
Discharge date
Discharge date
The amount suckled per day
Discharge date
Study Arms (2)
Indwelling nasogastric tube placement
ACTIVE COMPARATORIntermittent orogastric tube placement
ACTIVE COMPARATORInterventions
The premature infant is fed with an indwelling nasogastric tube during feeding transition.
The premature infant is fed with an intermittently placed orogastric tube during feeding transition.
Premature infants will be fed with a nasogastric tube in place and their feeding behaviors will be noted till discharge.
Premature infants will be fed with intermittent orogastric tube placement and their feeding behaviors will be noted till discharge.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Intermediate Care Unit, Health Sciences Centre
Winnipeg, Manitoba, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Judy A Kublick, Grad student
University of Manitoba
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2008
First Posted
November 26, 2008
Study Start
August 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
October 13, 2010
Record last verified: 2010-10