Preterm Neonatal Feeding Protocol Comparing Feed Administration Time

Feeding Intolerance Clinical Trial

Official title:

Preterm Neonatal Feeding Protocol Comparing Feed Administration Time

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997854
• Other study ID #: 5376
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Feeding Intolerance

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.