Preterm Neonatal Feeding Protocol Comparing Feed Administration Time
1 other identifier
interventional
136
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2009
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
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 15, 2009
CompletedFirst Posted
Study publicly available on registry
October 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJune 10, 2019
June 1, 2019
1 year
October 15, 2009
June 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Daily
Secondary Outcomes (3)
To compare the number of days it takes the infant to reach full feeds.
After reaching full feeds.
To compare the number of days the infant requires intravenous nutrition.
After reaching full feeds.
To compare the number of days of overall hospitalization duration.
After patient discharge.
Study Arms (2)
Group 1 Bolus Feeds
ACTIVE COMPARATORThis group will receive feeds administered by bolus method over no more than 30 minutes per feed.
Group 2- Slow Infusion Feeds
EXPERIMENTALThis group will receive feeds administered by slow infusion over pump for 2 hours.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Sciences University
Portland, Oregon, 97201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sue Ann Smith, MD
Oregon Health and Science University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Neonatologist
Study Record Dates
First Submitted
October 15, 2009
First Posted
October 19, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
June 10, 2019
Record last verified: 2019-06