Back to resultsPreterm Neonatal Feeding Protocol Comparing Feed Administration Time
Primary Purpose
Feeding Intolerance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Length of time for feed administration
Sponsored by
About this trial
This is an interventional prevention trial for Feeding Intolerance focused on measuring Feeding, Intolerance, Preterm, Bolus
Eligibility Criteria
Inclusion Criteria:
- Any infant born at OHSU or transferred in from another facility whose birthweight is greater than 500 grams and less than 1500 grams, and whose gestational age is less than 32 weeks.
Exclusion Criteria:
Any infant who has major anomalies including but not limited to *gastroschisis
- omphalocele
- bowel obstruction or atresia
- tracheo-esophageal fistula
- Hirschsprung's Disease
- congenital diaphragmatic hernia
- congenital heart disease and other major syndromes
- infants who have started enteral feeds prior to entering the study
- Any infant whose birth weight is greater than or equal to 1500 grams or less than 500 grams
- Any infant whose gestational age is greater than 32 weeks.
Sites / Locations
- Oregon Health & Sciences University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1 Bolus Feeds
Group 2- Slow Infusion Feeds
Arm Description
This group will receive feeds administered by bolus method over no more than 30 minutes per feed.
This group will receive feeds administered by slow infusion over pump for 2 hours.
Outcomes
Primary Outcome Measures
To compare feeding intolerance between these two groups as defined by the following criteria: the number of times that the signs and symptoms in an infant caused the perception of feeding intolerance with feeds paused for longer than one feeding.
Secondary Outcome Measures
To compare the number of days it takes the infant to reach full feeds.
To compare the number of days the infant requires intravenous nutrition.
To compare the number of days of overall hospitalization duration.
Full Information
NCT ID
NCT00997854
First Posted
October 15, 2009
Last Updated
June 6, 2019
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT00997854
Brief Title
Preterm Neonatal Feeding Protocol Comparing Feed Administration Time
Official Title
Preterm Neonatal Feeding Protocol Comparing Feed Administration Time
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Doctors have tried many different methods of feeding to try to decrease feeding intolerance in preterm babies so that they spend less time receiving liquid nutrition and have fewer problems with feeding intolerance.
The purpose of this study is to test two different methods of feeding preterm babies in the hopes of identifying a method that will decrease some of the feeding intolerance that can occur when feeding premature babies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Intolerance
Keywords
Feeding, Intolerance, Preterm, Bolus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 Bolus Feeds
Arm Type
Active Comparator
Arm Description
This group will receive feeds administered by bolus method over no more than 30 minutes per feed.
Arm Title
Group 2- Slow Infusion Feeds
Arm Type
Experimental
Arm Description
This group will receive feeds administered by slow infusion over pump for 2 hours.
Intervention Type
Other
Intervention Name(s)
Length of time for feed administration
Intervention Description
Group 1 will consist of babies fed by bolus method, administered over no more than 30 minutes. Group 2 will be fed by slow infusion by pump over 2 hours.
Primary Outcome Measure Information:
Title
To compare feeding intolerance between these two groups as defined by the following criteria: the number of times that the signs and symptoms in an infant caused the perception of feeding intolerance with feeds paused for longer than one feeding.
Time Frame
Daily
Secondary Outcome Measure Information:
Title
To compare the number of days it takes the infant to reach full feeds.
Time Frame
After reaching full feeds.
Title
To compare the number of days the infant requires intravenous nutrition.
Time Frame
After reaching full feeds.
Title
To compare the number of days of overall hospitalization duration.
Time Frame
After patient discharge.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any infant born at OHSU or transferred in from another facility whose birthweight is greater than 500 grams and less than 1500 grams, and whose gestational age is less than 32 weeks.
Exclusion Criteria:
Any infant who has major anomalies including but not limited to *gastroschisis
omphalocele
bowel obstruction or atresia
tracheo-esophageal fistula
Hirschsprung's Disease
congenital diaphragmatic hernia
congenital heart disease and other major syndromes
infants who have started enteral feeds prior to entering the study
Any infant whose birth weight is greater than or equal to 1500 grams or less than 500 grams
Any infant whose gestational age is greater than 32 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Ann Smith, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
12. IPD Sharing Statement
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Preterm Neonatal Feeding Protocol Comparing Feed Administration Time
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