Preterm Neonatal Feeding Protocol Comparing Feed Administration Time

Study Overview
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Brief Summary
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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.

Official Title
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Preterm Neonatal Feeding Protocol Comparing Feed Administration Time

Conditions
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Feeding Intolerance

Intervention / Treatment
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* Other: Length of time for feed administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 Bolus Feeds<br>This group will receive feeds administered by bolus method over no more than 30 minutes per feed. | Other: Length of time for feed administration<br>* 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.<br>|
| Experimental: Group 2- Slow Infusion Feeds<br>This group will receive feeds administered by slow infusion over pump for 2 hours. | Other: Length of time for feed administration<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | Daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feeding, Intolerance, Preterm, Bolus