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CompletedNCT00997854Updated Jun 10, 2019

Preterm Neonatal Feeding Protocol Comparing Feed Administration Time

An interventional study of Length of time for feed administration in Feeding Intolerance, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged Up to 32 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-10.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
Up to 32 Weeks
Sex
All
01

Study 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.

02

Conditions studied

  • Feeding Intolerance

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Keywords

  • Feeding
  • Intolerance
  • Preterm
  • Bolus
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 136 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 32 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherLength 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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. To compare the number of days it takes the infant to reach full feeds.

    Time frame: After reaching full feeds.

  2. To compare the number of days the infant requires intravenous nutrition.

    Time frame: After reaching full feeds.

  3. To compare the number of days of overall hospitalization duration.

    Time frame: After patient discharge.

07

Study locations

1 site
  • Oregon Health & Sciences University
    Portland, Oregon 97201, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00997854
Lead sponsor
Oregon Health and Science University
Responsible party
Sue Ann Smith (MD, Neonatologist, Oregon Health and Science University) — Principal investigator
First posted
Oct 19, 2009
Start date
Oct 2009
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Jun 10, 2019

Study contacts

Sue Ann Smith, MD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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