Preterm Neonatal Feeding Protocol Comparing Feed Administration Time

June 6, 2019 updated by: Sue Ann Smith, Oregon Health and Science University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health & Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Daily

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the number of days it takes the infant to reach full feeds.
Time Frame: After reaching full feeds.
After reaching full feeds.
To compare the number of days the infant requires intravenous nutrition.
Time Frame: After reaching full feeds.
After reaching full feeds.
To compare the number of days of overall hospitalization duration.
Time Frame: After patient discharge.
After patient discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Sue Ann Smith, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 18, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Actual)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 6, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5376

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe