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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00997854
Other study ID # 5376
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2009
Est. completion date October 2010

Study information

Verified date June 2019
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 32 Weeks
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Oregon Health & Sciences University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 To compare the number of days it takes the infant to reach full feeds. After reaching full feeds.
Secondary To compare the number of days the infant requires intravenous nutrition. After reaching full feeds.
Secondary To compare the number of days of overall hospitalization duration. After patient discharge.
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