Re-feeding Gastric Residuals in Preterm Infants

Study Overview
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Brief Summary
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The purpose of this study is to determine whether re-feeding of gastric residuals reduces the time needed to establish full enteral feedings in premature infants. Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Primary outcome measure is time to establish full enteral feedings (120cc/kg/day).

Detailed Description
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Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Feeding advancement determined by clinical physicians.

Official Title
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Re-feeding Residuals Versus Feeding Fresh Formula/Milk for Feeding Intolerance in Premature Infants

Conditions
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Premature; Infant, Light-for-dates

Intervention / Treatment
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* Procedure: Re-feeding residuals
* Procedure: Fresh Feeding Breastmilk or Formula only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age between 23.0 and 28.6 weeks; Receiving intravenous fluids but not enteral nutrition more than trophic feeds; Written informed consent from the parents Exclusion Criteria: Major congenital/chromosomal anomalies; Moribund infant with low likelihood of survival, in the opinion of the clinical team

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Re-feeding gastric residuals<br>In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be re-fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours. | Procedure: Re-feeding residuals<br>* In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be re-fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.<br>|
| Active Comparator: Fresh feeding breastmilk/formula only<br>In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be discarded and fresh breast milk or formula will be fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours. | Procedure: Fresh Feeding Breastmilk or Formula only<br>* In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be discarded and fresh breastmilk or formula will be fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to establish full enteral feeding | Time required to reach enteral feeding at 120cc/kg/day | Birth to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding intolerance | Feeding intolerance defined as interruption or cessation of enteral feeds for a perod greater than 12 hours for presence of bloody gastric residuals or an abnormal abdominal examination. | Birth to 28 days | 
| Episodes of feeding intolerance resulting in a interruption or cessation of progression of enteral feeds for a period of < 12 hours. | Number of episodes of feeding intolerance resulting in an interruption or cessation of progression of enteral feedings for a period of < 12 hours. | Birth to 28 days | 
| Number of days receiving parenteral nutrition | Total number of days or partial day receiving parenteral nutrition | Birth to 28 days | 
| Duration of hospital stay | Length of hospital stay in days | Birth to 120 days or discharge, whichever occurs first. | 
| Diagnosis of necrotizing enterocolitis | Diagnosis of necrotizing enterocolitis, Bell's Staging II-IV | Birth to 120 days or discharge, whichever occurs first. | 
| Diagnosis of intestinal perforation | Diagnosis of intestinal perforation between birth and 120 days or discharge, whichever occurs first. | Birth to 120 days or discharge, whichever occurs first | 
| Death | Death prior to 121 days of age. | Birth to 120 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature infant, feeding, residuals, fresh feeds, full feeds, digestive system