Preterm Neonatal Feeding Protocol Comparing Feed Administration Time
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Oregon Health and Science University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Oregon Health and Science University
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00997854
First received: October 15, 2009
Last updated: July 21, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Feeding Intolerance |
Other: Length of time for feed administration |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Preterm Neonatal Feeding Protocol Comparing Feed Administration Time |
Further study details as provided by Oregon Health and Science University:
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. [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To compare the number of days it takes the infant to reach full feeds. [ Time Frame: After reaching full feeds. ] [ Designated as safety issue: No ]
- To compare the number of days the infant requires intravenous nutrition. [ Time Frame: After reaching full feeds. ] [ Designated as safety issue: No ]
- To compare the number of days of overall hospitalization duration. [ Time Frame: After patient discharge. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 136 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1 Bolus Feeds
This group will receive feeds administered by bolus method over no more than 30 minutes per feed.
|
Other: Length of time for feed administration
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.
|
|
Experimental: Group 2- Slow Infusion Feeds
This group will receive feeds administered by slow infusion over pump for 2 hours.
|
Other: Length of time for feed administration
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| Ages Eligible for Study: | up to 32 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997854
Contacts
| Contact: Laura L Corbin, MD | 503-494-2613 | corbinl@ohsu.edu |
| Contact: Sue Ann Smith, MD | 503-494-3137 | smithsue@ohsu.edu |
Locations
| United States, Oregon | |
| Oregon Health & Sciences University | Recruiting |
| Portland, Oregon, United States, 97201 | |
| Contact: Deborah Golden-Eppelein 503-494-4853 | |
| Principal Investigator: Sue Ann Smith, MD | |
| Sub-Investigator: Laura L Corbin, MD | |
Sponsors and Collaborators
Oregon Health and Science University
Investigators
| Principal Investigator: | Sue Ann Smith, MD | Oregon Health and Science University |
More Information
No publications provided
| Responsible Party: | Sue Ann Smith, MD, Oregon Health & Sciences University |
| ClinicalTrials.gov Identifier: | NCT00997854 History of Changes |
| Other Study ID Numbers: | 5376 |
| Study First Received: | October 15, 2009 |
| Last Updated: | July 21, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
Feeding Intolerance Preterm Bolus |
ClinicalTrials.gov processed this record on May 23, 2013