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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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014