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Completed

NCT Number: NCT00997854

Preterm Neonatal Feeding Protocol Comparing Feed Administration Time

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.

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Key information

Conditions

Feeding Intolerance Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Sciences University

Portland, Oregon, 97201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Length of time for feed administration

Other

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.

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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 19, 2009
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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