Preterm Neonatal Feeding Protocol Comparing Feed Administration Time

Not Applicable

Completed

• Conditions: Feeding Intolerance
• Interventions: Other: Length of time for feed administration

• Registration Number: NCT00997854
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-18
• Study First Posted: 2009-10-19
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2- Slow Infusion Feeds	Length of time for feed administration	This group will receive feeds administered by slow infusion over pump for 2 hours.
Group 1 Bolus Feeds	Length of time for feed administration	This group will receive feeds administered by bolus method over no more than 30 minutes per feed.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Oregon Health & Sciences University; 🇺🇸 Portland, Oregon, United States